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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: dietary intervention with no-carrageenan diet; Dietary supplement: carrageenan

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: University of Chicago; The Broad Foundation
• Investigators: Principal Investigator: Joanne Tobacman, M.D., University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 4, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (Estimate): February 9, 2010

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: relapse; carrageenan; inflammation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 2009-0073

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No