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Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Illinois at Chicago
Sponsor:
Collaborators:
The Broad Foundation
University of Chicago
Information provided by (Responsible Party):
Joanne Kramer Tobacman, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01065571
First received: February 4, 2010
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.


Condition Intervention
Ulcerative Colitis
Dietary Supplement: carrageenan
Other: dietary intervention with no-carrageenan diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Time to relapse [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • laboratory parameters of inflammation [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carrageenan-free diet with placebo
This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis.
Other: dietary intervention with no-carrageenan diet
The intervention will consist of the no-carrageenan diet.
Active Comparator: carrageenan-free diet w/ carrageenan
The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption.
Dietary Supplement: carrageenan
The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.

Detailed Description:

This study will evaluate the interval to relapse in patients with ulcerative colitis. The patients will be adults, who have been in remission for at least one month. They will have previously required corticosteroids to induce remission. Subjects will be instructed in a no-carrageenan diet and required to follow this diet for the duration of their participation in the clinical study. They will be randomized to receive either placebo capsules or capsules containing carrageenan 100 mg. In this way, the study will be a double blind study of no-carrageenan vs. carrageenan. Main study outcome is the interval to relapse. Since ulcerative colitis is associated with relapses, relapse is anticipated. Other outcome measures will include scores on questionnaires, including the SSCAI and the SIDBQ, and laboratory measurements of inflammation.

Subjects will participate for one year or until relapse, with study visits every three months and telephone contacts every two weeks. After three months, participants will increase to two capsules daily, of either placebo or carrageenan.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ulcerative colitis
  • Adult
  • In remission
  • Required corticosteroids to induce remission
  • Able to make food choices and follow diet

Exclusion Criteria:

  • Not able to make food choices
  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: NCT01065571

Contacts
Contact: Joanne K Tobacman, M.D. 312-569-7826 jkt@uic.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Stephen B. Hanauer, M.D.    773-702-1466    shanauer@bsd.uchicago.edu   
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Joanne K. Tobacman, M.D.    312-569-7826    jkt@uic.edu   
Principal Investigator: Joanne K. Tobacman, M.D.         
Sponsors and Collaborators
University of Illinois at Chicago
The Broad Foundation
University of Chicago
  More Information

No publications provided

Responsible Party: Joanne Kramer Tobacman, Associate Professor of Clinical Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01065571     History of Changes
Other Study ID Numbers: 2009-0073
Study First Received: February 4, 2010
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
relapse
carrageenan
inflammation

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014