Pancreatic Enzyme Supplementation for Celiac Disease

Beth Israel Lahey Health

Status and phase: Terminated; Phase 4

Conditions: Celiac Disease

Treatments: Drug: pancrelipase

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02475369

2014P000375

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups

PES, Then Placebo

Other group

Description:

Participants first received Pancreatic Enzyme Supplementation (PES) for 10 days. PES taken 6 times daily with gluten free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received placebo tablets (matching PES treatment) 6 times daily for 10 days.

Treatment:

Drug: pancrelipase

Placebo, Then PES

Other group

Description:

Participants first received placebo tablets (matching PES) for 10 days. Placebo was taken 6 times daily with gluten-free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received PES tablets six times daily for 10 days.

Treatment:

Drug: pancrelipase