Trial record 7 of 10 for:    gluten | Open Studies | United States

Pancreatic Enzyme Supplementation for Celiac Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Actavis Inc.
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT02475369
First received: June 16, 2015
Last updated: February 24, 2016
Last verified: February 2016
  Purpose

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.

Condition Intervention Phase
Celiac Disease
Drug: pancrelipase
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of the Efficacy of Pancreatic Enzyme Supplementation for Symptom Control in Celiac Disease Not Responding to the Gluten Free Diet

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • reduction of gastrointestinal symptoms [ Time Frame: 34 days ] [ Designated as safety issue: No ]
    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 GSRRS on treatment versus on placebo for each subject).


Secondary Outcome Measures:
  • fecal elastase measurement [ Time Frame: 34 days ] [ Designated as safety issue: No ]
    Baseline fecal elastase measurement will be correlated to the average difference in on-treatment score in the Celiac Disease Gastrointestinal Symptom Rating Scale [active versus placebo].


Estimated Enrollment: 40
Study Start Date: May 2015
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1

pancrelipase: 3 (three) 20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase tablets with meals and 2 (two) 20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase tablets with snacks.

And Placebo

Drug: pancrelipase
Other Names:
  • Viokase
  • lipase, protease, amylase
Group 2

pancrelipase: 3 (three) 20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase tablets with meals and 2 (two) 20,880 USP units of lipase; 78,300 USP units of protease; 78,300 USP units of amylase tablets with snacks.

And placebo

Drug: pancrelipase
Other Names:
  • Viokase
  • lipase, protease, amylase

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02475369

Contacts
Contact: Josh Hansen, MS 617-667-8397 jhansen@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Josh Hansen, MS    617-667-8397    jhansen@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Actavis Inc.
Investigators
Principal Investigator: Ciaran Kelly, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02475369     History of Changes
Other Study ID Numbers: 2014-P-000375 
Study First Received: June 16, 2015
Last Updated: February 24, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
pancreatic enzyme supplementation

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 24, 2016