Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

Ulcerative Colitis Clinical Trial

Official title:

Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065571
• Other study ID #: 2009-0073
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: November 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	The Broad Foundation, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Relapses by Group	log-rank test to test for difference in number of relapses by group	up to one year of participation for each enrolled subject
Secondary	Fecal Calprotectin (Microgram/Gram Stool)	paired t-test comparing mean values at baseline and at end of study participation by group	one year or relapse or withdrawal compared with baseline
Secondary	Serum Interleukin-6 (pg/ml)	Difference in IL-6 between groups between baseline and end of study participation	change in IL-6 between baseline and up to one year of study participation