Pancreatic Enzyme Supplementation for Celiac Disease

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Celiac Disease

In brief

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.

Key facts

Study ID

NCT02475369

Run by

Beth Israel Deaconess Medical Center

People needed

21

Starts

2015-05-01

Expected to finish

2019-12-01

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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