Clinical trial NCT02475369: Pancreatic Enzyme Supplementation for Celiac Disease
Official title: Pilot Study of the Efficacy of Pancreatic Enzyme Supplementation for Symptom Control in Celiac Disease Not Responding to the Gluten Free Diet
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Celiac Disease
Keywords: pancreatic enzyme supplementation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Actavis Inc.
First posted: 2015-06-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change of Gastrointestinal Symptoms
timeFrame: Measured at end of each 10- day treatment period
Secondary outcomes:
measure: Correlation of Baseline Fecal Elastase and Celiac Disease Gastrointestinal Symptom Response at End of PES Treatment
timeFrame: Baseline visit (fecal elastase levels measured) and end of PES treatment period (CeD-GSRS scores measured)
measure: Change in Celiac Symptom Index Scores
timeFrame: Measured at the end of each 10-day treatment period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Ciaran Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.
citation: Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.