Pancreatic Enzyme Supplementation for Celiac Disease

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PES, Then Placebo

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.

Group Type OTHER

pancrelipase

Intervention Type DRUG

Placebo, Then PES

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.

Group Type OTHER

pancrelipase

Intervention Type DRUG

Interventions

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pancrelipase

Intervention Type DRUG

Other Intervention Names

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Viokase lipase, protease, amylase

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No