search
Back to results

Pancreatic Enzyme Supplementation for Celiac Disease

Primary Purpose

Celiac Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pancrelipase
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring pancreatic enzyme supplementation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

PES, Then Placebo

Placebo, Then PES

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 16, 2015
Last Updated
April 20, 2021
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Actavis Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02475369
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
The trial was terminated prematurely by the sponsor for administrative reasons.
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Actavis Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
pancreatic enzyme supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PES, Then Placebo
Arm Type
Other
Arm 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.
Arm Title
Placebo, Then PES
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
pancrelipase
Other Intervention Name(s)
Viokase, lipase, protease, amylase
Primary Outcome Measure Information:
Title
Change of Gastrointestinal Symptoms
Description
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.
Time Frame
Measured at end of each 10- day treatment period
Secondary Outcome Measure Information:
Title
Correlation of Baseline Fecal Elastase and Celiac Disease Gastrointestinal Symptom Response at End of PES Treatment
Description
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.
Time Frame
Baseline visit (fecal elastase levels measured) and end of PES treatment period (CeD-GSRS scores measured)
Title
Change in Celiac Symptom Index Scores
Description
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.
Time Frame
Measured at the end of each 10-day treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ciaran Kelly, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23163616
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.
Results Reference
background
PubMed Identifier
3123181
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.
Results Reference
background

Learn more about this trial

Pancreatic Enzyme Supplementation for Celiac Disease

We'll reach out to this number within 24 hrs