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

February 4, 2010
August 6, 2013
January 2010
January 2014   (final data collection date for primary outcome measure)
Time to relapse [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01065571 on ClinicalTrials.gov Archive Site
laboratory parameters of inflammation [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Ulcerative Colitis
  • Dietary Supplement: carrageenan
    The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
  • Other: dietary intervention with no-carrageenan diet
    The intervention will consist of the no-carrageenan diet.
  • 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.
    Intervention: Other: dietary intervention with 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.
    Intervention: Dietary Supplement: carrageenan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Joanne K Tobacman, M.D. 312-569-7826 jkt@uic.edu
United States
 
NCT01065571
2009-0073
Yes
Joanne Kramer Tobacman, University of Illinois at Chicago
University of Illinois at Chicago
  • The Broad Foundation
  • University of Chicago
Not Provided
University of Illinois at Chicago
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP