Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

Not Applicable

Completed

• Conditions: Ulcerative Colitis
• Interventions: Other: dietary intervention with no-carrageenan diet; Dietary Supplement: carrageenan

• Registration Number: NCT01065571
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Results First Submitted: 2018-04-30
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Results First Posted: 2019-11-26
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carrageenan-free diet with placebo	dietary intervention with no-carrageenan diet	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.
carrageenan-free diet w/ carrageenan	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.

Primary Outcome Measures

Name	Time	Method
Number of Relapses by Group	up to one year of participation for each enrolled subject	log-rank test to test for difference in number of relapses by group

Secondary Outcome Measures

Name	Time	Method
Serum Interleukin-6 (pg/ml)	change in IL-6 between baseline and up to one year of study participation	Difference in IL-6 between groups between baseline and end of study participation
Fecal Calprotectin (Microgram/Gram Stool)	one year or relapse or withdrawal compared with baseline	paired t-test comparing mean values at baseline and at end of study participation by group

Trial Locations

Locations (2)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States