Boston, Massachusetts 02215


Purpose:

The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. This protocol specifically aims to: 1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet. 2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.


Criteria:

Inclusion Criteria: - Biopsy proven celiac disease. - Age 18-80. - Ongoing symptoms defined as a CeD-GSRS score of greater than 3 during the run in period. - Subject must be following a gluten free diet. - tTG < 40 units at screening. Exclusion Criteria: - Taking prescription or over the counter enzyme supplements for 1 month prior to enrollment. - Pregnant, breastfeeding or planning pregnancy. Woman using acceptable methods of contraception will be included. Acceptable methods of contraception include oral hormonal contraceptives, implanted hormonal contraceptives, diaphragm with spermicide, condoms, intra-uterine device, abstinence, and male partner vasectomy. - Patients with a pork allergy or who are unwilling to consume pork products. - English proficiency unsuitable for completion of surveys. - Known severe pancreatic disease. - Known history of prior cancer (except squamous or basal cell skin cancer). - Patients with lactose intolerance who are unable to tolerate a minimum of 1oz (2 tablespoons) of whole milk per day. - Clinically significant abnormality in safety lab values (i.e. CBC and BMP) at screening that may impact subject safety or the scientific integrity of the study. - Other known active GI condition including but not limited to inflammatory bowel disease, small intestine bacterial overgrowth, and obvious FODMAP intolerance. - History of all major gastrointestinal surgery other than appendectomy or cholecystectomy. - Comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study.


NCT ID:

NCT02475369


Primary Contact:

Principal Investigator
Ciaran Kelly, MD
Beth Israel Deaconess Medical Center

Sarah Madoff, BS
Phone: 617-667-8266
Email: semadoff@bidmc.harvard.edu


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States

Sarah Madoff, BS
Phone: 617-667-8266
Email: semadoff@bidmc.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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