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Research at the Celiac Center

Research at the Celiac Center
Updated October 2013

New discovery about celiac disease and diabetes

Watch the video and learn more:

 

Patients with celiac disease have a lower prevalence of non-insulin-dependent diabetes mellitus and metabolic syndrome.

Kabbani TA, Kelly CP, Betensky RA, Hansen J, Pallav K, Villafuerte-Gálvez JA, Vanga R, Mukherjee R, Novero A, Dennis M, Leffler DA.

Gastroenterology. 2013 May;144(5):912-917.e1. doi: 10.1053/j.gastro.2013.01.033. Epub 2013 Jan 24.

Celiac Center Research

An Invitation to Donate

Here at the Celiac Center, we rely on several different avenues to support our research in celiac disease - grants from outside sponsors, donations from celiac organizations and, most personally, from our patients. We are most grateful for donations in any amount to fund current and future studies on celiac disease - with your help we have become one of the leading celiac research centers in the U.S. We encourage you to consider making a donation, perhaps in someone's name, or making us a part of your estate planning. Thank you very much in advance.

For donations, please contact:

Kathleen Cotter
Director, Major Gifts
617-667-1387
kcotter@bidmc.harvard.edu

Are you interested in celiac disease research?

The Celiac Center at Beth Israel Deaconess Medical Center is one of the leading sites for celiac disease research worldwide. In order to continue to make important advancements in our understanding and treatment of celiac disease, we are constantly in need of individuals with celiac disease to participate in research studies. We invite you to join our Celiac Research Contact List so that we may provide you with information on current and upcoming study opportunities.

Important points to consider:

  • Participation in this database and any studies you may be contacted about is strictly voluntary.
  • Your decision to, or not to, participate will not affect your relationship with your clinicians or with Beth Israel Deaconess Medical Center.
  • You can remove your information from this Contact List at any time by contacting the Celiac Center.
  • This database will be maintained by the Department of Gastroenterology under Dr. Daniel Leffler's supervision.

Would you like to join the Celiac Research Contact List and hear about research studies that might interest you?

Please contact the Celiac Center at 617-667-8397 or celiac@bidmc.harvard.edu with as much of the following information as you would like to provide:

  • Name
  • The best way to contact you (phone number, address and/or email address)
  • Date of birth (some studies have age requirements)
  • Date of diagnosis of celiac disease
  • Was the diagnosis of celiac disease confirmed with an intestinal biopsy (yes/no)

Current Studies & Clinicians' Contributions

If you would like to learn more about one of the studies below, please contact:
Celiac Clinical Trials
Celiac@BIDMC.Harvard.edu
Phone: 617-667-8397
For a list of our clinicians' contributions to research and clinical presentations, scroll to the bottom.

Have you had celiac disease for over a year and still have ongoing symptoms?  If so, you may be eligible to participate in a celiac research study.

Alvine Pharmaceuticals is testing a new drug to treat celiac disease.

The Celiac Center at Beth Israel Deaconess Medical Center is looking for people who have biopsy-proven celiac disease and have current stomach or intestinal symptoms felt to be related to celiac disease.

Participants will maintain their current diet throughout the study and you will not be given gluten.

The research study will involve taking either the study drug or a placebo for 12 weeks and coming to BIDMC in Boston for 7 study visits.

Participants will be asked to take a phone-based questionnaire every day. There will be two upper endoscopies during the study and blood and urine tests will be done at most visits.

You will be compensated for your time and parking.    

An Assessment of Neurocognitive Symptoms After Gluten Exposure in Adult Patients with Celiac Disease - A Pilot Study

Are you on a Gluten-Free Diet?

Do you experience 'Brain Fog', difficulty concentrating, thinking, or remembering after exposure to gluten?

If so, you may be eligible to participate in a research study.

The Celiac Center at BIDMC in Boston is doing a new study to determine why some people experience cognitive symptoms with gluten exposure.

Subjects will be asked to come to BIDMC for 3 visits, take questionnaires, have blood drawn, and eat a small amount of gluten once.

Our Thanks and Appreciation

We would like to give heartfelt thanks to our supporters who make large and long-term studies possible.

In particular, we offer our special thank you to the many individuals who have made charitable donations to the Celiac Center from their own personal resources.

Projects Funded by Our Supporters:



Alba Therapeutics
"A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects During Gluten Challenge"

Many thanks to the 20+ individuals who participated in the second Alba clinical trial to test the efficacy, safety and tolerability of a drug that might be used to treat celiac disease. Data analysis by the drug sponsor is underway and we hope to share the results in the coming year. With your help we continue to be one of the leading sites in the U.S. for emerging celiac disease research. Your continued participation is essential to seeing this field move forward.


Alvine Pharmaceuticals, Inc.
"Circulating Markers of Celiac Disease Activity During Gluten Challenge - A Pilot Study"

Despite great advances in our understanding of celiac disease, there is currently no validated instrument for monitoring the activity of this common disorder other than small intestinal biopsy. The identification of accurate non-invasive measures of celiac disease activity would be of great value in clinical practice, are prerequisite to the testing of new treatment modalities and may also offer insight into disease pathogenesis. Currently, patient care and clinical research in celiac disesae are hindered by the lack of validated non-invasive measures of disease activity. We hypothesize that a combination of disease specific surveys and biological markers will allow development of a composite index which will accurately reflect disease activity.

The specific aims of this study are; 1) To develop and evaluate survey tool for use in celiac disease. Measurements will include: A. symptoms, B. gluten free diet adherence and C. health related quality of life. 2) To rigorously evaluate and compare the ability of non-invasive tests of celiac disease activity to predict change in villous height to crypt depth ratio during gluten challenge. 3) To develop a composite model of celiac disease activity using measures from aims 1 and 2 correlated with intestinal histologic change during gluten challenge. Validity will be assessed in two independent cohorts, and data from these studies will be used to design a final multi-center validation study.

Celiac Sprue Association/USA, Inc., and The Healthy Villi
"Correlates of Gluten Free Diet Adherence in Adults with Celiac Disease"

Researchers in the Celiac Center have been working on a number of ongoing studies examining the symptoms of celiac disease and adherence to the gluten free diet. This work has generated important data on quality of life, the psychological factors that influence diet adherence, and on the nutritional quality of the gluten free diet and has launched two novel survey tools which will aid clinicians in standardizing symptoms and gluten free dietary adherence.

The Sidney Frank Foundation
"Campaign to Improve Awareness of Celiac Disease Amongst Primary Care Physicians"

Although the most current epidemiological studies have shown that the prevalence of CD in the general population of Europe and the U.S. is between 0.5 and 1%, the majority of cases continue to be undiagnosed (Catassi et al., 2007; Zipser, Farid, Baisch, Patel, & Patel, 2005). The two primary reasons as to why CD is believed to remain undiagnosed despite the prevalence of CD predicted by surveys and epidemiological studies using the mass serological screening include the lack of awareness and education of the disease among PCPs, as well as the atypical symptoms that patients tend to present.

Furthermore, PCPs are regularly presented with patients experiencing CD but who have yet to be diagnosed, thus allowing for the case-finding strategy to be one of the most effective ways to increase the diagnostic rate of CD (Catassi, Kryszak, Louis-Jacques, et al., 2007; Fasano & Catassi, 2001; Hin, Bird, Fisher, Mahy, & Jewell, 1999). The case-finding strategy consists of identifying the most common symptoms and comorbidity associated with CD and then seeking out patients who fulfill the criteria. Once the case-finding strategy has been used to discover at-risk individuals, serological tests, including the tTG, should be used to screen the individuals. Catassi et al. (2007) report that CD is particularly frequent amongst patients presenting with thyroid disease, chronic diarrhea, and irritable bowel syndrome. Hin et al. (1999) have found that non-specific symptoms including anemia, diabetes, chronic fatigue, and a family history of CD were the most common among patients with undiagnosed CD. Hin et al. (1999) also suggest that the case finding strategy should be used and in doing so PCPs should emphasize on direct questioning since anemia and chronic fatigue may not be symptoms a patient typically states, as compared to more noticeable symptoms such as gastrointestinal. In fact, Hin et al. (1999) reports that of the 225 patients presenting with gastrointestinal symptoms, only five of those patients were diagnosed with CD. Primary care physicians should learn to search outside the box by focusing on current findings as opposed to conforming to the common perception that CD was amongst those who experienced gastrointestinal symptoms such as chronic diarrhea, abdominal distention, and weight loss (Fasano & Catassi, 2001). Other non-classic symptoms include osteoporosis, infertility, neurologic problems, dental enamel hypoplasia, and dermatitis herpetiformis. One way for PCPs to deem the case-finding strategy would be to remember the phrase, "think of celiac disease and you will find it" (Fasano & Catassi, 2001).

In sum, it is evident that PCPs are in need of a consistent and proper method to learn about CD. The investigators propose to develop a set of educational tools for this population to use based on the most recent research.

The Celiac Center team has thus partnered with local and national organizations to create two online continuing medical education programs on celiac disease aimed primarily at primary care providers. Links to these programs are below:

http://cme.hms.harvard.edu/index.asp

http://www.celiaccmecentral.com/

Journal Publications, Reviews, Editorials

Leffler D, Vanga R, Mukherjee R. Mild enteropathy celiac disease: a wolf in sheep's clothing? Clin Gastroenterol Hepatol. 2013 Mar;11(3):259-61.

Vanga R, Leffler D. Gluten  sensitivity: not celiac and not certain. Gastroenterology. 2013 Aug;145(2):276-9.

Leffler D, Schuppan D, Pallav K, Najarian R, Goldsmith JD, Hansen J, Kabbani T, Dennis M, Kelly CP. Kinetics of the histological, serological and symptomatic responses to gluten challenge in adults with coeliac disease. Gut. 2013 Jul;62(7):996-1004. 

Kabbani TA, Kelly CP, Betensky RA, Hansen J, Pallav K, Villafuerte-Gálvez JA, Vanga R, Mukherjee R, Novero A, Dennis M, Leffler DA. Patients with celiac disease have a lower prevalence of non-insulin-dependent diabetes mellitus and metabolic syndrome. Gastroenterology. 2013 May;144(5):912-917. 

Tanpowpong P, Broder-Fingert S, Obuch JC, Rahni DO, Katz AJ, Leffler DA, Kelly CP, Camargo CA Jr. Multicenter study on the value of ICD-9-CM codes for case identification of celiac disease. Ann Epidemiol. 2013 Mar;23(3):136-42.

Tanpowpong P, Obuch JC, Jiang H, McCarty CE, Katz AJ, Leffler DA, Kelly CP, Weir DC, Leichtner AM, Camargo CA Jr. Multicenter study on season of birth and celiac disease: evidence for a new theoretical model of pathogenesis. J Pediatr. 2013 Mar;162(3):501-4.

Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Commentary: larazotide acetate - an exciting new development for coeliac patients? Authors' reply. Aliment Pharmacol Ther. 2013 Feb;37(4):496-7.

Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62.

Ludvigsson JF, Leffler DA, Bai JC, Biagi F, Fasano A, Green PH, Hadjivassiliou M, Kaukinen K, Kelly CP, Leonard JN, Lundin KE, Murray JA, Sanders DS, Walker MM, Zingone F, Ciacci C. The Oslo definitions for coeliac disease and related terms. Gut. 2013 Jan;62(1):43-52.

Junker Y, Zeissig S, Kim SJ, Barisani D, Wieser H, Leffler DA, Zevallos V, Libermann TA, Dillon S, Freitag TL, Kelly CP, Schuppan D. Wheat amylase trypsin inhibitors drive intestinal inflammation via activation of toll-like receptor 4. J Exp Med. 2012 Dec 17;209(13):2395-408.

Mukherjee R, Kelly CP, Schuppan D. Nondietary therapies for celiac disease. Gastrointest Endosc Clin N Am. 2012 Oct; 22(4):811-31.

Leffler DA, Kelly CP, Abdallah HZ, Colatrella AM, Harris LA, Leon F, Arterburn LA, Paterson BM, Lan ZH, Murray JA. A Randomized, Double-Blind Study of Larazotide Acetate to Prevent the Activation of Celiac Disease during Gluten Challenge. Am J Gastroenterol. 2012 Oct;107:1554-62.

Leffler DA. Clinical Crossroads: A 46 Year Old Female with Celiac Disease. JAMA 2011 Oct 12; 06(14):1582-92.

Panzer RM, Dennis M, Kelly CP, Weir D, Leichtner A, Leffler DA. Navigating the Gluten Free Diet in College. J Pediatr Gastroenterol Nutr. 2012 Jun 22.

Kabbani TA, Goldberg A, Kelly CP, Pallav K, Tariq S, Peer A, Hansen J, Dennis M, Leffler DA. Body mass index and the risk of obesity in coeliac disease treated with the gluten-free diet. Aliment Pharmacol Ther. 2012 Mar;35(6):723-9.

Ludvigsson JF, Leffler DA, Bai JC, Biagi F, Fasano A, Green PH, Hadjivassiliou M, Kaukinen K, Kelly CP, Leonard JN, Lundin KE, Murray JA, Sanders DS, Walker MM, Zingone F, Ciacci C. The Oslo definitions for coeliac disease and related terms. Gut. 2012 Feb 16.

Pallav K, Leffler DA, Bennett M, Tariq S, Xu H, Kabbani T, Moss AC, Dennis M, Kelly CP, Schuppan D. Open conformation tissue transglutaminase testing for celiac dietary assessment. Dig Liver Dis. 2012 Jan 17.

Mukherjee R, Kelly CP, Leffler DA. Gastrointestinal cancer in celiac disease: "the first days are the hardest days, don't you worry anymore?" Clin Gastroenterol Hepatol (2012 Jan) 10(1):4-6.

Pallav K, Leffler DA, Tariq S, Kabbani T, Hansen J, Peer A, Bhansali A, Najarian R, Kelly CP. Noncoeliac enteropathy: the differential diagnosis of villous atrophy in contemporary clinical practice. Aliment Pharmacol Ther. 2012;35(3):380-90.

Floch MH, Walker WA, Madsen K, Sanders ME, Macfarlane GT, Flint HJ, Dieleman LA, Ringel Y, Guandalini S, Kelly CP, Brandt LJ. Recommendations for probiotic use-2011 update. J Clin Gastroenterol. 2011 Nov; 45 Suppl: S168-71.

Mukherjee R, Kelly CP, Leffler DA. Gastrointestinal Cancer in Celiac Disease: "The First Days Are the Hardest Days, Don't You Worry Anymore?" Clin Gastroenterol Hepatol. 2011 Oct 5.

Roshan B, Leffler DA, Jamma S, Dennis M, Sheth S, Falchuk M, Najarian R, Goldsmith J, Tariq S, Schuppan D, Kelly CP. The Incidence and Clinical Spectrum of Refractory Celiac Disease in a North American Referral Center. Am J Gastroenterol 2011 May;106:923-8.

Leffler DA, Neema N, Rabb JM, Shin JY, Landon BE, Pallav, K, Falchuk ZM, Aronson M. A Randomized Trial of an Alerting System to Improve Adherence to Colonoscopy Follow-up Recommendations. Gastroenterology. 2011 Apr;140(4):1166-1173.e1-3.

Jamma S, Leffler DA, Dennis M, Najarian RM, Schuppan DB, Sheth S, Kelly CP. Small Intestinal Release Mesalamine for the Treatment of Refractory Celiac Disease Type I. J Clin Gastroenterol. 2011;45:30-3.

Leffler DA, Kelly CP. Celiac disease and gastroesophageal reflux disease: yet another presentation for a clinical chameleon. Clin Gastroenterol Hepatol. 2011;9:192-3.

Leffler DA, Kheraj R, Garud S, Neeman N, Nathanson LA, Kelly CP, et al. The incidence and cost of unexpected hospital use after scheduled outpatient endoscopy. Arch Intern Med 2010 Oct;170(19):1752-7.

Jamma S, Rubio-Tapia A, Kelly CP, Murray J, Sheth S, Schuppan D, Dennis M, Leffler DA. Celiac Crisis: An uncommon but serious complication of celiac disease in adults. Clin Gastroenterol & Hepatol 2010;8:587-90.

Books and Book Chapters

Mukherjee R, Kelly CP.  Diseases Producing Malabsorption and Maldigestion, Gastroenterology Section of American College of Physicians (ACP) Medicine. (in press)

Kelly CP, Dennis MD. Celiac Disease in Adults: Beyond the Basics. Up to Date. www.uptodate.com, 2012.

Leffler DA, Cardenas A, Kelly CP. Celiac disease. Hawkey, Bosch, Richter, Garcia-Tsao, Chan editors. Clinical Gastroenterology and Hepatology (2nd edition). Wiley-Blackwell, Chichester, 2012, pp288-298.

Dennis M, Kupper C, Lee AR, Sharrett MK, Thompson T. Celiac Disease Toolkit. Academy of Nutrition & Dietetics, 2011.

Leffler D, Dennis M. Nutritional Management of Celiac Disease. AGA Nutrition Toolkit Series (On-line CME Module), American Gastroenterological Press, Bethesda, MA, October 2010.

Farrell RJ, Kelly CP. Celiac Disease and Refractory Celiac Disease. Feldman, Friedman, and Brandt, editors. Sleisenger & Fordtran's Gastrointestinal and Liver Disease, 9th edition. W B Saunders Co., Philadelphia. 2010, p1797-1820.

Dennis M, Leffler D. Real Life with Celiac Disease: Troubleshooting and Thriving Gluten-Free. AGA Press, Bethesda, MD, 2010.

Dennis M, Kupper C, Lee AR, Sharrett MK, Thompson T. Celiac Disease Toolkit. Academy's (ADA) Evidence-Based Nutrition Practice Guidelines. Academy of Nutrition & Dietetics, 2009.

Contact Information

Celiac Disease Center
Beth Israel Deaconess Medical Center
East Campus, Dana 601
330 Brookline Avenue
Boston, MA 02215
617-667-1272