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Celiac Disease: HELP
Articles by Ciaran P. Kelly
Based on 53 articles published since 2010
(Why 53 articles?)
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Between 2010 and 2020, C. Kelly wrote the following 53 articles about Celiac Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline ACG clinical guidelines: diagnosis and management of celiac disease. 2013

Rubio-Tapia, Alberto / Hill, Ivor D / Kelly, Ciarán P / Calderwood, Audrey H / Murray, Joseph A / Anonymous3950756. ·Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, USA. ·Am J Gastroenterol · Pubmed #23609613.

ABSTRACT: This guideline presents recommendations for the diagnosis and management of patients with celiac disease. Celiac disease is an immune-based reaction to dietary gluten (storage protein for wheat, barley, and rye) that primarily affects the small intestine in those with a genetic predisposition and resolves with exclusion of gluten from the diet. There has been a substantial increase in the prevalence of celiac disease over the last 50 years and an increase in the rate of diagnosis in the last 10 years. Celiac disease can present with many symptoms, including typical gastrointestinal symptoms (e.g., diarrhea, steatorrhea, weight loss, bloating, flatulence, abdominal pain) and also non-gastrointestinal abnormalities (e.g., abnormal liver function tests, iron deficiency anemia, bone disease, skin disorders, and many other protean manifestations). Indeed, many individuals with celiac disease may have no symptoms at all. Celiac disease is usually detected by serologic testing of celiac-specific antibodies. The diagnosis is confirmed by duodenal mucosal biopsies. Both serology and biopsy should be performed on a gluten-containing diet. The treatment for celiac disease is primarily a gluten-free diet (GFD), which requires significant patient education, motivation, and follow-up. Non-responsive celiac disease occurs frequently, particularly in those diagnosed in adulthood. Persistent or recurring symptoms should lead to a review of the patient's original diagnosis to exclude alternative diagnoses, a review of the GFD to ensure there is no obvious gluten contamination, and serologic testing to confirm adherence with the GFD. In addition, evaluation for disorders associated with celiac disease that could cause persistent symptoms, such as microscopic colitis, pancreatic exocrine dysfunction, and complications of celiac disease, such as enteropathy-associated lymphoma or refractory celiac disease, should be entertained. Newer therapeutic modalities are being studied in clinical trials, but are not yet approved for use in practice. Given the incomplete response of many patients to a GFD-free diet as well as the difficulty of adherence to the GFD over the long term, development of new effective therapies for symptom control and reversal of inflammation and organ damage are needed. The prevalence of celiac disease is increasing worldwide and many patients with celiac disease remain undiagnosed, highlighting the need for improved strategies in the future for the optimal detection of patients.

2 Editorial The Potential for Treatment of Potential Celiac Disease. 2016

Silvester, Jocelyn A / Kelly, Ciarán P. ·Celiac Disease Research Program, Harvard Medical School, Boston Children's Hospital, Boston, Massachusetts; University of Manitoba College of Medicine, Department of Pediatrics, Winnipeg, Manitoba, Canada. · Celiac Center, Beth Israel Deaconess Medical Center, Celiac Research Program, Harvard Medical School, Boston, Massachusetts. ·Clin Gastroenterol Hepatol · Pubmed #26767312.

ABSTRACT: -- No abstract --

3 Editorial The cost of a loaf of bread in symptomless celiac disease. 2014

Leffler, Daniel A / Kelly, Ciarán P. ·Department of Medicine, Harvard Medical School and Celiac Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Department of Medicine, Harvard Medical School and Celiac Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: ckelly2@bidmc.harvard.edu. ·Gastroenterology · Pubmed #25072177.

ABSTRACT: -- No abstract --

4 Editorial Gastrointestinal cancer in celiac disease: "the first days are the hardest days, don't you worry anymore?". 2012

Mukherjee, Rupa / Kelly, Ciarán P / Leffler, Daniel A. · ·Clin Gastroenterol Hepatol · Pubmed #21982968.

ABSTRACT: -- No abstract --

5 Editorial Celiac disease and gastroesophageal reflux disease: yet another presentation for a clinical chameleon. 2011

Leffler, Daniel A / Kelly, Ciarán P. · ·Clin Gastroenterol Hepatol · Pubmed #21145426.

ABSTRACT: -- No abstract --

6 Review Novel Nondietary Therapies for Celiac Disease. 2019

Alhassan, Eaman / Yadav, Abhijeet / Kelly, Ciaran P / Mukherjee, Rupa. ·Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. · Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: rmukherj@bidmc.harvard.edu. ·Cell Mol Gastroenterol Hepatol · Pubmed #31146067.

ABSTRACT: Celiac Disease (CeD) is defined as a chronic small intestinal immune-mediated enteropathy that is precipitated by exposure to dietary gluten in genetically predisposed individuals. CeD is one of the most common autoimmune disorders affecting around 1% of the population worldwide. Currently, the only acceptable treatment for CeD is strict, lifelong adherence to a gluten-free diet (GFD) which can often present a challenging task. A GFD alone is not sufficient to control symptoms and prevent mucosal damage that can result from unintentional gluten exposure. Moreover, long-term complications can occur in many patients. Consequently, there is an unmet need for non-dietary therapies for the management of CeD. Such therapies could serve as an adjunct to the GFD but eventually may replace it. This review will focus on and discuss non-dietary therapies currently in clinical development for the management of CeD. METHODOLOGY: We searched clinicaltrials.gov and PubMed to extract articles about celiac disease. We used keywords including, but not limited to, "celiac disease," "non-dietary," "therapeutics," "pathophysiology," "Endopeptidases," "tight junction modulators," "vaccine," and "Nexvax2". We focused mainly on articles that conducted pathophysiologic and therapeutic research in human trials.

7 Review Nondietary Therapies for Celiac Disease. 2019

Serena, Gloria / Kelly, Ciaran P / Fasano, Alessio. ·Division of Pediatric Gastroenterology and Nutrition, Mucosal Immunology and Biology Research Center, MassGeneral Hospital for Children, 175 Cambridge Street, CPZS - 574, Boston, MA 02114, USA; Celiac Research Program, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA. · Celiac Research Program, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA. · Division of Pediatric Gastroenterology and Nutrition, Mucosal Immunology and Biology Research Center, MassGeneral Hospital for Children, 175 Cambridge Street, CPZS - 574, Boston, MA 02114, USA; Celiac Research Program, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA. Electronic address: AFASANO@mgh.harvard.edu. ·Gastroenterol Clin North Am · Pubmed #30711207.

ABSTRACT: Celiac disease (CD) is an autoimmune enteropathy triggered by gluten. Gluten-free diets can be challenging because of their restrictive nature, inadvertent cross-contaminations, and the high cost of gluten-free food. Novel nondietary therapies are at the preclinical stage, clinical trial phase, or have already been developed for other indications and are now being applied to CD. These therapies include enzymatic gluten degradation, binding and sequestration of gluten, restoration of epithelial tight junction barrier function, inhibition of tissue transglutaminase-mediated potentiation of gliadin oligopeptide immunogenicity or of human leukocyte antigen-mediated gliadin presentation, induction of tolerance to gluten, and antiinflammatory interventions.

8 Review Measuring Change In Small Intestinal Histology In Patients With Celiac Disease. 2018

Adelman, Daniel C / Murray, Joseph / Wu, Tsung-Teh / Mäki, Markku / Green, Peter H / Kelly, Ciarán P. ·Department of Medicine, Division of Allergy and Immunology, University of California, San Francisco, San Francisco, CA, USA. · Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA. · Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. · Faculty of Medicine and Life Sciences, University of Tampere and Tampere University Hospital, Tampere, Finland. · Celiac Disease Center, Columbia University, New York, NY, USA. · Celiac Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. ·Am J Gastroenterol · Pubmed #29460921.

ABSTRACT: Small intestinal histologic abnormalities in celiac disease include atrophy of the intestinal villi, hypertrophy of the crypts and lymphocytic infiltration of intraepithelial spaces and lamina propria. These findings are central to diagnosis and their severity and change over time are valuable to monitor disease course and response to therapy. Subjective methods to grade celiac disease histological severity include the Marsh-Oberhuber and Corazza-Villanacci systems. Quantitative histology uses villus height (Vh), crypt depth (Cd), and intra-epithelial lymphocyte count (per 100 enterocytes) to provide objective measures of histologic changes including Vh:Cd ratio. Here we examine the available literature regarding these methodologies and support the use of quantitative histology as the preferred method for accurately and reproducibly demonstrating change of relevant histologic end points over time. We also propose a Quantitative-Mucosal Algorithmic Rules for Scoring Histology (Q-MARSH) system to partially align quantitative histology results with the traditional Marsh, Marsh-Oberhuber, and Corazza-Villanacci systems. Q-MARSH can provide a standardized, objective, and quantitative histology scoring system for use as a clinical or research application.

9 Review Tests for Serum Transglutaminase and Endomysial Antibodies Do Not Detect Most Patients With Celiac Disease and Persistent Villous Atrophy on Gluten-free Diets: a Meta-analysis. 2017

Silvester, Jocelyn A / Kurada, Satya / Szwajcer, Andrea / Kelly, Ciarán P / Leffler, Daniel A / Duerksen, Donald R. ·Max Rady College of Medicine, University of Manitoba, Winnipeg; Celiac Research Program, Harvard Medical School, Boston, Massachusetts; Boston Children's Hospital, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Celiac Research Program, Harvard Medical School, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts. · University of Manitoba Health Sciences Libraries, Winnipeg, Manitoba, Canada. · Max Rady College of Medicine, University of Manitoba, Winnipeg. Electronic address: dduerkse@sbgh.mb.ca. ·Gastroenterology · Pubmed #28545781.

ABSTRACT: BACKGROUND & AIMS: Tests to measure serum endomysial antibodies (EMA) and antibodies to tissue transglutaminase (tTG) were developed to screen for celiac disease in patients consuming gluten. However, they are commonly used to monitor patients on a gluten-free diet (GFD). We conducted a meta-analysis to assess the sensitivity and specificity of tTG IgA and EMA IgA assays in identifying patients with celiac disease who have persistent villous atrophy despite a GFD. METHODS: We searched PUBMED, EMBASE, BIOSIS, SCOPUS, clinicaltrials.gov, Science Citation Index, and Cochrane Library databases through November 2016. Inclusion criteria were studies of subjects with biopsy-confirmed celiac disease, follow-up biopsies, and measurement of serum antibodies on a GFD, biopsy performed on subjects regardless of symptoms, or antibody test results. Our analysis excluded subjects with refractory celiac disease, undergoing gluten challenge, or consuming a prescribed oats-containing GFD. Tests were considered to have positive or negative findings based on manufacturer cut-off values. Villous atrophy was defined as a Marsh 3 lesion or villous height:crypt depth ratio below 3.0. We constructed forest plots to determine the sensitivity and specificity of detection for individual studies. For the meta-analysis, a bivariate random effects model was used to jointly model sensitivity and specificity. RESULTS: Our search identified 5408 unique citations. Following review of abstracts, 442 articles were reviewed in detail. Only 26 studies (6 of tTG assays, 15 of EMA assays, and 5 of tTG and EMA assays) met our inclusion criteria. The most common reason studies were excluded from our analysis was inability to cross-tabulate histologic and serologic findings. The serum assays identified patients with persistent villous atrophy with high levels of specificity: 0.83 for the tTG IgA assay (95% CI, 0.79-0.87) and 0.91 for the EMA IgA assay (95% CI, 0.87-0.94). However, they detected villous atrophy with low levels of sensitivity: 0.50 for the tTG IgA assay (95% CI, 0.41-0.60) and 0.45 for the EMA IgA assay (95% CI, 0.34-0.57). The tests had similar levels of performance in pediatric and adult patients. CONCLUSIONS: In a meta-analysis of patients with biopsy-confirmed celiac disease undergoing follow-up biopsy on a GFD, we found that tests for serum tTG IgA and EMA IgA levels had low sensitivity (below 50%) in detection of persistent villous atrophy. We need more-accurate non-invasive markers of mucosal damage in children and adults with celiac disease who are following a GFD.

10 Review Current Status of Celiac Disease Drug Development. 2016

Wungjiranirun, Manida / Kelly, Ciaran P / Leffler, Daniel A. ·Division of Gastroenterology, The Celiac Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. ·Am J Gastroenterol · Pubmed #27021196.

ABSTRACT: Celiac disease (CeD) is one of the most common immune-mediated diseases. Symptoms and disease activity are incompletely controlled by the gluten-free diet, which is currently the only available therapy. Although no therapies are yet approved, there is a growing field of candidates and an improving understanding of the regulatory pathway. In this review, we briefly discuss the epidemiology, pathophysiology, and current treatment paradigm for CeD. We also review the major classes of therapies being considered for CeD and discuss extensively what is known and can be surmised regarding the regulatory pathway for approval of a CeD therapeutic. The coming years will see an increasing number and diversity of potential therapies entering clinical trials and hopefully the first approved agents targeting this significant unmet medical need. Although biomarkers including histology and serology will always be important in therapeutic clinical trials, they currently lack the necessary evidence linking them to improved patient outcomes required for use as primary outcomes for drug approval. For this reason, patient-reported outcomes will likely be primary end points in Phase III CeD trials for the foreseeable future.

11 Review Celiac Disease: Diagnostic Standards and Dilemmas. 2015

Kaswala, Dharmesh H / Veeraraghavan, Gopal / Kelly, Ciaran P / Leffler, Daniel A. ·The Celiac Center, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA. dkaswala@bidmc.harvard.edu. · The Celiac Center, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA. gveerara@bidmc.harvard.edu. · The Celiac Center, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA. ckelly2@bidmc.harvard.edu. · The Celiac Center, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA. dleffler@bidmc.harvard.edu. ·Diseases · Pubmed #28943611.

ABSTRACT: Celiac Disease (CD) affects at least 1% of the population and evidence suggests that prevalence is increasing. The diagnosis of CD depends on providers being alert to both typical and atypical presentations and those situations in which patients are at high risk for the disease. Because of variable presentation, physicians need to have a low threshold for celiac testing. Robust knowledge of the pathogenesis of this autoimmune disease has served as a catalyst for the development of novel diagnostic tools. Highly sensitive and specific serological assays including Endomysial Antibody (EMA), tissue transglutaminase (tTG), and Deamidated Gliadin Peptide (DGP) have greatly simplified testing for CD and serve as the foundation for celiac diagnosis. In addition, genetic testing for HLA DQ2 and DQ8 has become more widely available and there has been refinement of the gluten challenge for use in diagnostic algorithms. While diagnosis is usually straightforward, in special conditions including IgA deficiency, very young children, discrepant histology and serology, and adoption of a gluten free diet prior to testing, CD can be difficult to diagnose. In this review, we provide an overview of the history and current state of celiac disease diagnosis and provide guidance for evaluation of CD in difficult diagnostic circumstances.

12 Review Advances in diagnosis and management of celiac disease. 2015

Kelly, Ciarán P / Bai, Julio C / Liu, Edwin / Leffler, Daniel A. ·Celiac Program, Harvard Medical School and Department of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: ckelly2@bidmc.harvard.edu. · Hospital Gastroenterologia, and Department of Gastroenterology, School of Medicine, Universidad del Salvador, Buenos Aires, Argentina. · Colorado Center for Celiac Disease, Digestive Health Institute, Children's Hospital Colorado, Aurora, Colorado; Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado. · Celiac Program, Harvard Medical School and Department of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. ·Gastroenterology · Pubmed #25662623.

ABSTRACT: Celiac disease is an autoimmune disorder that is induced by dietary gluten in genetically predisposed individuals. It has a prevalence of approximately 1% in many populations worldwide. New diagnoses have increased substantially, owing to increased awareness, better diagnostic tools, and probable real increases in incidence. The breadth of recognized clinical presentations continues to expand, making the disorder highly relevant to all physicians. Newer diagnostic tools, including serologic tests for antibodies against tissue transglutaminase and deamidated gliadin peptide, greatly facilitate diagnosis. Tests for celiac-permissive HLA-DQ2 and HLA-DQ8 molecules are useful in defined clinical situations. Celiac disease is diagnosed by histopathologic examination of duodenal biopsy specimens. However, according to recent controversial guidelines, a diagnosis can be made without a biopsy in certain circumstances, especially in children. Symptoms, mortality, and risk for malignancy each can be reduced by adherence to a gluten-free diet. This treatment is a challenge, however, because the diet is expensive, socially isolating, and not always effective in controlling symptoms or intestinal damage. Hence, there is increasing interest in developing nondietary therapies.

13 Review Nondietary therapies for celiac disease. 2012

Mukherjee, Rupa / Kelly, Ciaran P / Schuppan, Detlef. ·Department of Medicine, Division of Gastroenterology, The Celiac Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA. rmukherj@bidmc.harvard.edu ·Gastrointest Endosc Clin N Am · Pubmed #23083995.

ABSTRACT: Currently, the only available therapy for celiac disease is strict lifelong adherence to a gluten-free diet (GFD). Although safe and effective, the GFD is not ideal. It is frequently expensive, of limited nutritional value, and not readily available in many countries. Consequently, a need exists for novel, nondietary therapies for celiac disease. Based on the current understanding of celiac disease pathogenesis, several potential targets of therapeutic intervention exist. These novel strategies provide promise of alternative, adjunctive treatment options but also raise important questions regarding safety, efficacy, and monitoring of long-term treatment effect.

14 Clinical Trial No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. 2017

Murray, Joseph A / Kelly, Ciarán P / Green, Peter H R / Marcantonio, Annette / Wu, Tsung-Teh / Mäki, Markku / Adelman, Daniel C / Anonymous6950887. ·Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. Electronic address: murray.joseph@mayo.edu. · Celiac Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. · Columbia University College of Physicians and Surgeons, New York, New York. · Alvine Pharmaceuticals, San Carlos, California. · Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota. · School of Medicine, University of Tampere and Tampere University Hospital, Tampere, Finland. ·Gastroenterology · Pubmed #27864127.

ABSTRACT: BACKGROUND & AIMS: Gluten ingestion leads to symptoms and small intestinal mucosal injury in patients with celiac disease. The only option is the strict lifelong exclusion of dietary gluten, which is difficult to accomplish. Many patients following a gluten-free diet continue to have symptoms and have small intestinal mucosal injury. Nondietary therapies are needed. We performed a phase 2 study of the ability of latiglutenase, an orally administered mixture of 2 recombinant gluten-targeting proteases, to reduce mucosal morphometric measures in biopsy specimens from patients with celiac disease. METHODS: We performed a double-blind, placebo-controlled, dose-ranging study to assess the efficacy and safety of latiglutenase in 494 patients with celiac disease (with moderate or severe symptoms) in North America and Europe, from August 2013 until December 2014. Participants reported following a gluten-free diet for at least 1 year before the study began. Patients with documented moderate or severe symptoms and villous atrophy (villous height:crypt depth ratio of ≤2.0) were assigned randomly to groups given placebo or 100, 300, 450, 600, or 900 mg latiglutenase daily for 12 or 24 weeks. Subjects completed the Celiac Disease Symptom Diary each day for 28 days and underwent an upper gastrointestinal endoscopy with duodenal biopsy of the distal duodenum at baseline and at weeks 12 and 24. The primary end point was a change in the villous height:crypt depth ratio. Secondary end points included numbers of intraepithelial lymphocytes, serology test results (for levels of antibodies against tissue transglutaminase-2 and deamidated gliadin peptide), symptom frequencies, and safety. RESULTS: In a modified intent-to-treat population, there were no differences between latiglutenase and placebo groups in change from baseline in villous height:crypt depth ratio, numbers of intraepithelial lymphocytes, or serologic markers of celiac disease. All groups had significant improvements in histologic and symptom scores. CONCLUSIONS: In a phase 2 study of patients with symptomatic celiac disease and histologic evidence of significant duodenal mucosal injury, latiglutenase did not improve histologic and symptom scores when compared with placebo. There were no significant differences in change from baseline between groups. ClinicalTrials.gov no: NCT01917630.

15 Clinical Trial Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. 2015

Leffler, Daniel A / Kelly, Ciaran P / Green, Peter H R / Fedorak, Richard N / DiMarino, Anthony / Perrow, Wendy / Rasmussen, Henrik / Wang, Chao / Bercik, Premysl / Bachir, Natalie M / Murray, Joseph A. ·The Celiac Center at Beth Israel Deaconess Medical Center, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Celiac Disease Center at Columbia University, New York, New York. · Center of Excellence for Gastrointestinal Immunity and Inflammation Research, University of Alberta, Edmonton, Alberta, Canada. · Thomas Jefferson University, Philadelphia, Pennsylvania. · Alba Therapeutics Corporation, Baltimore, Maryland. · McMaster University, Hamilton, Ontario, Canada. · Essentia Health Duluth Clinic, Duluth, Minnesota. · Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. Electronic address: Murray.joseph@mayo.edu. ·Gastroenterology · Pubmed #25683116.

ABSTRACT: BACKGROUND & AIMS: Celiac disease (CeD) is a prevalent autoimmune condition. Recurrent signs and symptoms are common despite treatment with a gluten-free diet (GFD), yet no approved or proven nondietary treatment is available. METHODS: In this multicenter, randomized, double-blind, placebo-controlled study, we assessed larazotide acetate 0.5, 1, or 2 mg 3 times daily to relieve ongoing symptoms in 342 adults with CeD who had been on a GFD for 12 months or longer and maintained their current GFD during the study. The study included a 4-week placebo run-in, 12 weeks of treatment, and a 4-week placebo run-out phase. The primary end point was the difference in average on-treatment Celiac Disease Gastrointestinal Symptom Rating Scale score. RESULTS: The primary end point was met with the 0.5-mg dose of larazotide acetate, with fewer symptoms compared with placebo by modified intention to treat (n = 340) (analysis of covariance, P = .022; mixed model for repeated measures, P = .005). The 0.5-mg dose showed an effect on exploratory end points including a 26% decrease in celiac disease patient-reported outcome symptomatic days (P = .017), a 31% increase in improved symptom days (P = .034), a 50% or more reduction from baseline of the weekly average abdominal pain score for 6 or more of 12 weeks of treatment (P = .022), and a decrease in the nongastrointestinal symptoms of headache and tiredness (P = .010). The 1- and 2-mg doses were no different than placebo for any end point. Safety was comparable with placebo. CONCLUSIONS: Larazotide acetate 0.5 mg reduced signs and symptoms in CeD patients on a GFD better than a GFD alone. Although results were mixed, this study was a successful trial of a novel therapeutic agent targeting tight junction regulation in patients with CeD who are symptomatic despite a GFD. Clinicaltrials.gov: NCT01396213.

16 Article Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. 2018

Singh, Prashant / Arora, Ananya / Strand, Tor A / Leffler, Daniel A / Catassi, Carlo / Green, Peter H / Kelly, Ciaran P / Ahuja, Vineet / Makharia, Govind K. ·Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Lady Hardinge Medical College, New Delhi, India. · Innlandet Hospital Trust, Lillehammer, Norway; Centre for International Health, University of Bergen, Bergen, Norway. · Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Gastroenterology Research and Development, Takeda Pharmaceuticals Inc, Cambridge, MA. · Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy. · Department of Medicine, Columbia University Medical Center, New York, New York; USA Celiac Disease Center, Columbia University Medical Center, New York, New York. · Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. · Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India. Electronic address: govindmakharia@aiims.edu. ·Clin Gastroenterol Hepatol · Pubmed #29551598.

ABSTRACT: BACKGROUND & AIMS: Celiac disease is a major public health problem worldwide. Although initially it was reported from countries with predominant Caucasian populations, it now has been reported from other parts of the world. The exact global prevalence of celiac disease is not known. We conducted a systematic review and meta-analysis to estimate the global prevalence of celiac disease. METHODS: We searched Medline, PubMed, and EMBASE for the keywords celiac disease, celiac, celiac disease, tissue transglutaminase antibody, anti-endomysium antibody, endomysial antibody, and prevalence for studies published from January 1991 through March 2016. Each article was cross-referenced with the words Asia, Europe, Africa, South America, North America, and Australia. The diagnosis of celiac disease was based on European Society of Pediatric Gastroenterology, Hepatology, and Nutrition guidelines. Of 3843 articles, 96 articles were included in the final analysis. RESULTS: The pooled global prevalence of celiac disease was 1.4% (95% confidence interval, 1.1%-1.7%) in 275,818 individuals, based on positive results from tests for anti-tissue transglutaminase and/or anti-endomysial antibodies (called seroprevalence). The pooled global prevalence of biopsy-confirmed celiac disease was 0.7% (95% confidence interval, 0.5%-0.9%) in 138,792 individuals. The prevalence values for celiac disease were 0.4% in South America, 0.5% in Africa and North America, 0.6% in Asia, and 0.8% in Europe and Oceania; the prevalence was higher in female vs male individuals (0.6% vs 0.4%; P < .001). The prevalence of celiac disease was significantly greater in children than adults (0.9% vs 0.5%; P < .001). CONCLUSIONS: In a systematic review and meta-analysis, we found celiac disease to be reported worldwide. The prevalence of celiac disease based on serologic test results is 1.4% and based on biopsy results is 0.7%. The prevalence of celiac disease varies with sex, age, and location. There is a need for population-based prevalence studies in many countries.

17 Article Determination of gluten consumption in celiac disease patients on a gluten-free diet. 2018

Syage, Jack A / Kelly, Ciarán P / Dickason, Matthew A / Ramirez, Angel Cebolla / Leon, Francisco / Dominguez, Remedios / Sealey-Voyksner, Jennifer A. ·ImmunogenX, Newport Beach, CA. · Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA. · Biomedal, Seville, Spain. ·Am J Clin Nutr · Pubmed #29529159.

ABSTRACT: Background: Celiac disease (CD) patients adhering to a gluten-free diet (GFD) are exposed frequently to low levels of gluten that contribute to symptoms and persistent intestinal histologic damage. Objective: We analyzed prior clinical data to determine how much gluten is accidentally consumed while on a GFD. The aim was to understand the range of gluten consumption for a wide distribution of CD patients. Design: A meta-analysis was conducted on data from 2 different clinical programs: 1) measurements of gluten in stool and urine in CD and non-CD populations; and 2) analysis of data from trials for the investigational therapeutic latiglutenase. The stool and urine studies included controlled gluten challenges. A calibration factor was applied that allowed normal ingestion of gluten to be computed from the urine and stool measurements. From the latiglutenase trial data, a determination of gluten consumption was made by estimating how much gluten was eliminated from patients' diets due to a trial effect that led to improved histology even in the placebo group. Results: The average inadvertent exposure to gluten by CD individuals on a GFD was estimated to be ∼150-400 (mean) and ∼100-150 (median) mg/d using the stool test and ∼300-400 (mean) and ∼150 (median) mg/d using the urine test. The analyses of the latiglutenase data for CD individuals with moderate to severe symptoms indicate that patients ingested significantly >200 mg/d of gluten. Conclusions: These surrogate biomarkers of gluten ingestion indicate that many individuals following a GFD regularly consume sufficient gluten to trigger symptoms and perpetuate intestinal histologic damage.

18 Article Self-reported dietary adherence, disease-specific symptoms, and quality of life are associated with healthcare provider follow-up in celiac disease. 2017

Hughey, Jacob J / Ray, Bonnie K / Lee, Anne R / Voorhees, Kristin N / Kelly, Ciaran P / Schuppan, Detlef. ·Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA. jakejhughey@gmail.com. · Talkspace, New York, NY, USA. · Celiac Disease Center, Columbia University Medical Center, New York, NY, USA. · Beyond Celiac, Ambler, PA, USA. · Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA. · Institute of Translational Immunology, University Medical Center, Mainz, Germany. ·BMC Gastroenterol · Pubmed #29228908.

ABSTRACT: BACKGROUND: The only treatment for celiac disease (CeD) is a lifelong gluten-free diet (GFD). The restrictive nature of the GFD makes adherence a challenge. As an integral part of CeD management, multiple professional organizations recommend regular follow-up with a healthcare provider (HCP). Many CeD patients also participate in patient advocacy groups (PAGs) for education and support. Previous work found that follow-up of CeD patients is highly variable. Here we investigated the self-reported factors associated with HCP follow-up among individuals diagnosed with CeD who participate in a PAG. METHODS: We conducted a survey of members of Beyond Celiac (a PAG), collecting responses from 1832 U.S. adults ages 19-65 who reported having CeD. The survey queried HCP follow-up related to CeD and included validated instruments for dietary adherence (CDAT), disease-specific symptoms (CSI), and quality of life (CD-QOL). RESULTS: Overall, 27% of respondents diagnosed with CeD at least five years ago reported that they had not visited an HCP about CeD in the last five years. The most frequent reason for not visiting an HCP was "doing fine on my own" (47.6%). Using multiple logistic regression, we identified significant associations between whether a respondent reported visiting an HCP about CeD in the last five years and the scores for all three validated instruments. In particular, as disease-specific symptoms and quality of life worsened, the probability of having visited an HCP increased. Conversely, as dietary adherence worsened, the probability decreased. CONCLUSIONS: Our results suggest that many individuals with CeD manage their disease without ongoing support from an HCP. Our results thus emphasize the need for greater access to high quality CeD care, and highlight an opportunity for PAGs to bring together patients and HCPs to improve management of CeD.

19 Article Symptoms of Functional Intestinal Disorders Are Common in Patients with Celiac Disease Following Transition to a Gluten-Free Diet. 2017

Silvester, Jocelyn A / Graff, Lesley A / Rigaux, Lisa / Bernstein, Charles N / Leffler, Daniel A / Kelly, Ciarán P / Walker, John R / Duerksen, Donald R. ·Rady College of Medicine, Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada. · Boston Children's Hospital, Harvard Medical School, Boston, MA, USA. · Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. · St. Boniface Hospital Research Center, Winnipeg, MB, USA. · Rady College of Medicine, Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada. donald.duerksen@umanitoba.ca. · St. Boniface Hospital Research Center, Winnipeg, MB, USA. donald.duerksen@umanitoba.ca. · Division of Gastroenterology, C5-120 St Boniface Hospital, 409 Tache Avenue, Winnipeg, MB, R2H 2A6, USA. donald.duerksen@umanitoba.ca. ·Dig Dis Sci · Pubmed #28687943.

ABSTRACT: BACKGROUND: Celiac disease and functional intestinal disorders may overlap, yet the natural history of functional symptoms in patients with celiac disease is unknown. AIM: To investigate the prevalence of irritable bowel syndrome (IBS), functional dyspepsia (FD), and functional bloating (FB) symptoms among patients with celiac disease at diagnosis and during the first year of a gluten-free diet. METHODS: Adults with a new diagnosis of celiac disease were surveyed at baseline, 6 months and 1 year using standardized measures for intestinal symptoms [Rome III diagnostic questionnaire and celiac symptom index (CSI)] and gluten-free diet adherence [gluten-free eating assessment tool (GF-EAT) and celiac diet adherence test]. RESULTS: At diagnosis, two-thirds fulfilled Rome III diagnostic questionnaire symptom criteria for IBS (52%), functional dyspepsia (27%), and/or functional bloating (9%). One year post-diagnosis, there was high adherence to a gluten-free diet as 93% reported gluten exposure less than once per month on the GF-EAT and only 8% had ongoing celiac disease symptoms (CSI score >45). The rates of those meeting IBS (22%) and functional dyspepsia (8%) symptom criteria both decreased significantly on a gluten-free diet. The prevalence of functional symptoms (any of IBS, FD or FB) at 1 year was 47%. CONCLUSIONS: Long-term follow-up of patients with celiac disease is necessary because many patients with celiac disease who are adherent to a gluten-free diet have persistent gastrointestinal symptoms.

20 Article A Novel Patient-Derived Conceptual Model of the Impact of Celiac Disease in Adults: Implications for Patient-Reported Outcome and Health-Related Quality-of-Life Instrument Development. 2017

Leffler, Daniel A / Acaster, Sarah / Gallop, Katy / Dennis, Melinda / Kelly, Ciarán P / Adelman, Daniel C. ·Celiac Center, Beth Israel Deaconess Medical Center, Boston, MA, USA; Celiac Research Program, Harvard Medical School, Boston, MA, USA. Electronic address: dleffler@bidmc.harvard.edu. · Acaster Consulting Ltd., London, UK. · Celiac Center, Beth Israel Deaconess Medical Center, Boston, MA, USA; Celiac Research Program, Harvard Medical School, Boston, MA, USA. · Alvine Pharmaceuticals, Inc., San Carlos, CA, USA. ·Value Health · Pubmed #28408006.

ABSTRACT: BACKGROUND: Celiac disease is a chronic inflammatory condition with wide ranging effects on individual's lives caused by a combination of symptoms and the burden of adhering to a gluten-free diet (GFD). OBJECTIVES: To further understand patients' experience of celiac disease, the impact it has on health-related quality of life (HRQOL), and to develop a conceptual model describing this impact. METHODS: Adults with celiac disease on a GFD reporting symptoms within the previous 3 months were included; patients with refractory celiac disease and confounding medical conditions were excluded. A semistructured discussion guide was developed exploring celiac disease symptoms and impact on patients' HRQOL. An experienced interviewer conducted in-depth interviews. The data set was coded and analyzed using thematic analysis to identify concepts, themes, and the inter-relationships between them. Data saturation was monitored and concepts identified formed the basis of the conceptual model. RESULTS: Twenty-one participants were recruited, and 32 distinct gluten-related symptoms were reported and data saturation was reached. Analysis identified several themes impacting patients' HRQOL: fears and anxiety, day-to-day management of celiac disease, physical functioning, sleep, daily activities, social activities, emotional functioning, and relationships. The conceptual model highlights the main areas of impact and the relationships between concepts. CONCLUSIONS: Both symptoms and maintaining a GFD have a substantial impact on patient functioning and HRQOL in adults with celiac disease. The conceptual model derived from these data may help to design future patient-reported outcomes as well as interventions to improve the quality of life in an individual with celiac disease.

21 Article Factors associated with villus atrophy in symptomatic coeliac disease patients on a gluten-free diet. 2017

Mahadev, S / Murray, J A / Wu, T-T / Chandan, V S / Torbenson, M S / Kelly, C P / Maki, M / Green, P H R / Adelman, D / Lebwohl, B. ·Celiac Disease Center, Columbia University College of Physicians and Surgeons, New York, USA. · Division of Gastroenterology and Hepatology, The Mayo Clinic, Rochester, MN, USA. · Department of Laboratory Medicine and Pathology, The Mayo Clinic, Rochester, MN, USA. · Celiac Center, Beth Israel Deaconess Medical Center and Celiac Research Program, Harvard Medical School, Boston, MA, USA. · Tampere Center for Child Health Research, School of Medicine, University of Tampere and Tampere University Hospital, Finland, Europe. · Division of Allergy/Immunology, Department of Medicine, University of California, San Francisco, CA, USA. ·Aliment Pharmacol Ther · Pubmed #28220520.

ABSTRACT: BACKGROUND: Duodenal injury persists in some coeliac disease patients despite gluten-free diet, and is associated with adverse outcomes. AIM: To determine the prevalence and clinical risk factors for persistent villus atrophy among symptomatic coeliac disease patients. METHODS: A nested cross-sectional analysis was performed on coeliac disease patients with self-reported moderate or severe symptoms while following a gluten-free diet, who underwent protocol-mandated duodenal biopsy upon enrolment in the CeliAction clinical trial. Demographic factors, symptom type, medication use, and serology were examined to determine predictors of persistent villus atrophy. RESULTS: Of 1345 symptomatic patients, 511 (38%, 95% CI, 35-41%) were found to have active coeliac disease with persistent villus atrophy, defined as average villus height to crypt depth ratio ≤2.0. On multivariable analysis, older age (OR, 5.1 for ≥70 vs. 18-29 years, 95% CI, 2.5-10.4) was a risk factor while longer duration on gluten-free diet was protective (OR, 0.37, 95% CI, 0.24-0.55 for 4-5.9 vs. 1-1.9 years). Villus atrophy was associated with use of proton-pump inhibitors (PPIs; OR, 1.6, 95% CI, 1.1-2.3), non-steroidal anti-inflammatory drugs (NSAIDs; OR, 1.64, 95% CI, 1.2-2.2), and selective serotonin reuptake inhibitors (SSRIs; OR, 1.74, 95% CI, 1.2-2.5). Symptoms were not associated with villus atrophy after adjusting for covariates. Conclusions A majority of symptomatic coeliac disease patients did not have active disease on follow-up histology. Symptoms were poorly predictive of persistent mucosal injury. The impact of NSAIDs, PPIs, and SSRIs on mucosal healing in coeliac disease warrants further study.

22 Article Salivary Gluten Degradation and Oral Microbial Profiles in Healthy Individuals and Celiac Disease Patients. 2017

Tian, Na / Faller, Lina / Leffler, Daniel A / Kelly, Ciaran P / Hansen, Joshua / Bosch, Jos A / Wei, Guoxian / Paster, Bruce J / Schuppan, Detlef / Helmerhorst, Eva J. ·Department of Molecular and Cell Biology, Boston University Henry M. Goldman School of Dental Medicine, Boston, Massachusetts, USA. · The Forsyth Institute, Department of Microbiology, Cambridge, Massachusetts, USA. · Celiac Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA. · Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands. · Department of Medical Psychology, Academic Medical Center, Amsterdam, The Netherlands. · Department of Oral Medicine, Infection, and Immunity, Harvard School of Dental Medicine, Boston, Massachusetts, USA. · Institute of Translational Immunology and Research Center for Immunotherapy (FZI), University Medical Center, Mainz, Germany. · Department of Molecular and Cell Biology, Boston University Henry M. Goldman School of Dental Medicine, Boston, Massachusetts, USA helmer@bu.edu. ·Appl Environ Microbiol · Pubmed #28087531.

ABSTRACT: Celiac disease (CD) is a chronic immune-mediated enteropathy induced by dietary gluten in genetically predisposed individuals. Saliva harbors the second highest bacterial load of the gastrointestinal (GI) tract after the colon. We hypothesized that enzymes produced by oral bacteria may be involved in gluten processing in the intestine and susceptibility to celiac disease. The aim of this study was to investigate salivary enzymatic activities and oral microbial profiles in healthy subjects versus patients with classical and refractory CD. Stimulated whole saliva was collected from patients with CD in remission (

23 Article Creation of a model to predict survival in patients with refractory coeliac disease using a multinational registry. 2016

Rubio-Tapia, A / Malamut, G / Verbeek, W H M / van Wanrooij, R L J / Leffler, D A / Niveloni, S I / Arguelles-Grande, C / Lahr, B D / Zinsmeister, A R / Murray, J A / Kelly, C P / Bai, J C / Green, P H / Daum, S / Mulder, C J J / Cellier, C. ·Mayo Clinic, Rochester, MN, USA. · Hopital Europeen Georges-Pompidou, Paris, France. · VU University Medical Centre, Amsterdam, The Netherlands. · Beth Israel Deaconess Medical Center, Boston, MA, USA. · Hospital Dr. Carlos Nonorino Udaondo, Buenos Aires, Argentina. · Columbia University Medical Center, New York, NY, USA. · Charite-University Medicine Berlin, Berlin, Germany. ·Aliment Pharmacol Ther · Pubmed #27485029.

ABSTRACT: BACKGROUND: Refractory coeliac disease is a severe complication of coeliac disease with heterogeneous outcome. AIM: To create a prognostic model to estimate survival of patients with refractory coeliac disease. METHODS: We evaluated predictors of 5-year mortality using Cox proportional hazards regression on subjects from a multinational registry. Bootstrap resampling was used to internally validate the individual factors and overall model performance. The mean of the estimated regression coefficients from 400 bootstrap models was used to derive a risk score for 5-year mortality. RESULTS: The multinational cohort was composed of 232 patients diagnosed with refractory coeliac disease across seven centres (range of 11-63 cases per centre). The median age was 53 years and 150 (64%) were women. A total of 51 subjects died during a 5-year follow-up (cumulative 5-year all-cause mortality = 30%). From a multiple variable Cox proportional hazards model, the following variables were significantly associated with 5-year mortality: age at refractory coeliac disease diagnosis (per 20 year increase, hazard ratio = 2.21; 95% confidence interval, CI: 1.38-3.55), abnormal intraepithelial lymphocytes (hazard ratio = 2.85; 95% CI: 1.22-6.62), and albumin (per 0.5 unit increase, hazard ratio = 0.72; 95% CI: 0.61-0.85). A simple weighted three-factor risk score was created to estimate 5-year survival. CONCLUSIONS: Using data from a multinational registry and previously reported risk factors, we create a prognostic model to predict 5-year mortality among patients with refractory coeliac disease. This new model may help clinicians to guide treatment and follow-up.

24 Article Low testosterone in non-responsive coeliac disease: A case series, case-control study with comparisons to the National Health and Nutrition Examination Survey. 2016

Kurada, Satya / Veeraraghavan, Gopal / Kaswala, Dharmesh / Hansen, Josh / Cohen, David / Kelly, Ciaran / Leffler, Daniel. ·Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA; Coeliac Research Program, Harvard Medical School, Boston, MA, USA. Electronic address: skurada@bidmc.harvard.edu. · Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA; Coeliac Research Program, Harvard Medical School, Boston, MA, USA. · Division of Endocrinology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. ·Dig Liver Dis · Pubmed #27378706.

ABSTRACT: BACKGROUND: Adults with coeliac disease (CD) often report persistent fatigue, even when CD appears well controlled for unknown reasons. AIMS: To evaluate common indications for testosterone panel (TP) testing and prevalence of low testosterone (T) in CD. METHODS: In our case series, we determined common indications for checking TP in CD. Next, we conducted a case-control study to compare TP in CD vs. healthy controls (HC). We compared mean total T (TT), free T (FT) based on serologic, histologic disease activity. Finally, we assessed TT in tissue transglutaminase (tTG)+ vs. tTG- subjects and CD vs. HC obtained from the National Health and Nutrition Examination Survey (NHANES). RESULTS: 53 coeliac males had TP tested. Common indications included osteoporosis and fatigue. Low FT was observed in 7/13 men with osteoporosis and 5/6 with fatigue. In our case-control study (n=26 each), there was no difference in mean TT or FT between CD vs. HC, tTG+ vs tTG- or Marsh 0 vs. Marsh 3 groups. NHANES data showed no difference in mean TT between tTG+ vs tTG- (n=16 each) or CD vs. HC subjects (n=5 each). CONCLUSIONS: Low T occurs in CD patients at a similar rate as the general population. Common presentations of low T may mimic non-responsive CD symptoms.

25 Article Serum I-FABP Detects Gluten Responsiveness in Adult Celiac Disease Patients on a Short-Term Gluten Challenge. 2016

Adriaanse, Marlou P M / Leffler, Daniel A / Kelly, Ciaran P / Schuppan, Detlef / Najarian, Robert M / Goldsmith, Jeffrey D / Buurman, Wim A / Vreugdenhil, Anita C E. ·Department of Pediatrics and Nutrition and Toxicology Research Institute Maastricht (NUTRIM), Maastricht University Medical Center, Maastricht, the Netherlands. · Department of Gastroenterology, Celiac Disease Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. · Institute of Translational Immunology, Research Center of Immunology (FZI), University Medical Center, Mainz, Germany. · Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. · Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands. ·Am J Gastroenterol · Pubmed #27185075.

ABSTRACT: OBJECTIVES: Response to gluten challenge (GC) is a key feature in diagnostic algorithms and research trials in celiac disease (CD). Currently, autoantibody titers, late responders to GC, and invasive duodenal biopsies are used to evaluate gluten responsiveness. This study investigated the accuracy of serum intestinal-fatty acid binding protein (I-FABP), a marker for intestinal epithelial damage, to predict intestinal damage during GC in patients with CD. METHODS: Twenty adult CD patients in remission underwent a two-week GC with 3 or 7.5 g of gluten daily. Study visits occurred at day -14, 0, 3, 7, 14, and 28. Serum I-FABP, antibodies to tissue transglutaminase (tTG-IgA), deamidated gliadin peptides (IgA-DGP), and anti-actin (AAA-IgA) were assessed at each visit. Villous-height to crypt-depth ratio (Vh:Cd) and intraepithelial lymphocyte (IEL) count were evaluated at day -14, 3, and 14. Forty-three CD-serology negative individuals were included to compare serum I-FABP levels in CD patients on a gluten-free diet (GFD) with those in healthy subjects. RESULTS: Serum I-FABP levels increased significantly during a two-week GC. In contrast, the most pronounced autoantibody increase was found at day 28, when patients had already returned to a GFD for two weeks. IgA-AAA titers were only significantly elevated at day 28. I-FABP levels and IEL count correlated at baseline (r=0.458, P=0.042) and at day 14 (r=0.654, P=0.002) of GC. Neither gluten dose nor time on a GFD influenced I-FABP change during GC. CONCLUSIONS: Serum I-FABP levels increased significantly during a two-week GC in adult CD patients and correlated with IEL count. The data suggest that serum I-FABP is an early marker of gluten-induced enteropathy in celiac patients and may be of use in both clinical and research settings.

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