Pancreatic Enzyme Supplementation for Celiac Disease

• Status: Terminated
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Actavis Inc.
• Treatments: Pancreatin; Pancrelipase

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.