Pancreatic Enzyme Supplementation for Celiac Disease

Celiac Disease Clinical Trial

Official title:

Pilot Study of the Efficacy of Pancreatic Enzyme Supplementation for Symptom Control in Celiac Disease Not Responding to the Gluten Free Diet

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02475369
• Other study ID #: 2014P000375
• Status: Terminated
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2021
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• pancrelipase

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Actavis Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Svedlund J, Sjödin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Gastrointestinal Symptoms	The average per individual subject on-treatment score in the Celiac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS) domains of Diarrhea, Indigestion, and Abdominal pain comparing active treatment to placebo (i.e. a paired comparison of CeD GSRS on treatment versus on placebo for each subject).; CeD-GSRS: Each individual sub-section of the 15 sub-sections scores from 1 to 7, with greater scores indicating worse symptoms. A total score can range from 15 -105. This is then divided by 15 to obtain the minimum overall CeD-GSRS score of 1 and maximum of 7. It has 3 domains- Abdominal pain, Indigestion and Diarrhea domains, each domain having a score ranging from 1-7. The higher the overall score, the more severe the symptoms.	Measured at end of each 10- day treatment period
Secondary	Correlation of Baseline Fecal Elastase and Celiac Disease Gastrointestinal Symptom Response at End of PES Treatment	Baseline fecal elastase measurement will be correlated with Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores at the end of PES treatment period.; Celiac Disease Gastrointestinal Symptom Response Scale:scores range from 1 to 7, with greater scores indicating worse symptoms. The minimum score obtainable is 15 and the maximum score obtainable is 105. This is then divided by 15 to obtain the minimum overall CeD-GSRS score of 1 and maximum of 7. It has 3 domains- Abdominal pain, Indigestion and Diarrhea domains, each domain having a score ranging from 1-7. The higher the overall score, the more severe the symptoms.	Baseline visit (fecal elastase levels measured) and end of PES treatment period (CeD-GSRS scores measured)
Secondary	Change in Celiac Symptom Index Scores	The average per individual subject on-treatment scores in the Celiac Symptom Index (CSI) comparing PES treatment to placebo.; For the Celiac Symptom Index: scores range from 16 to 80, with greater scores indicating worse symptoms; Leffler DA, Dennis M, Edwards George J, Jamma S, Cook EF, Schuppan D, Kelly CP. A validated disease-specific symptom index for adults with celiac disease. Clin Gastroenterol Hepatol. 2009;7:1328-34. PubMed PMID: 19665584.	Measured at the end of each 10-day treatment period