Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

NCT01065571 | Completed Results DMC

• 1 other identifier: 2009-0073
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

relapse; carrageenan; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fecal Calprotectin (Microgram/Gram Stool)

  one year or relapse or withdrawal compared with baseline

• Serum Interleukin-6 (pg/ml)

  change in IL-6 between baseline and up to one year of study participation

Study Arms (2)

carrageenan-free diet with placebo

EXPERIMENTAL

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

carrageenan-free diet w/ carrageenan

ACTIVE COMPARATOR

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

Interventions

carrageenan DIETARY_SUPPLEMENT

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

carrageenan-free diet w/ carrageenan

dietary intervention with no-carrageenan diet OTHER

The intervention will consist of the no-carrageenan diet.

carrageenan-free diet with placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ulcerative colitis
• Adult
• In remission
• Required corticosteroids to induce remission
• Able to make food choices and follow diet

You may not qualify if:

• Not able to make food choices

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• The Broad Foundation: collaborator
• University of Chicago: collaborator

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Recurrence; Inflammation

Interventions

Carrageenan; Diet Therapy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates; Nutrition Therapy; Therapeutics

Results Point of Contact

• Title: Joanne Tobacman, MD
• Organization: University of Illinois at Chicago

jkt@uic.edu

312-569-7826

Study Officials

• Joanne Tobacman, M.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 9, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: November 26, 2019
• Results First Posted: November 26, 2019

Record last verified: 2019-11

Locations

US (2)