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Completed

NCT Number: NCT01065571

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carrageenan

Dietary Supplement

The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.

dietary intervention with no-carrageenan diet

Other

The intervention will consist of the no-carrageenan diet.

Primary outcomes

  1. Number of Relapses by Group

    Time frame: up to one year of participation for each enrolled subject

    log-rank test to test for difference in number of relapses by group

Secondary outcomes

  1. Fecal Calprotectin (Microgram/Gram Stool)

    Time frame: 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

  2. Serum Interleukin-6 (pg/ml)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • The Broad Foundation
  • University of Chicago

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Feb 9, 2010
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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