9th Annual BMRP Investigator Meeting - Abstract
Effects of Carrageenan-Free Diet on Activity of Ulcerative Colitis
Joanne K. Tobacman1,a, Stephen Hanauer2, Jay Goldstein1, Theresa Shumard2, Lori Rowell2, Sumit Bhattahcharyya1, Shivani Katyal1, Rosemary West1 and Felecia Gilet1
1Department of Medicine, University of Illinois at Chicago (Chicago, Illinois, U.S.A.); 2Department of Medicine, The University of Chicago (Chicago, Illinois, U.S.A.)
The common food additive carrageenan is known to produce inflammation in animal models of colitis and to activate inflammatory pathways in cultured human colonic epithelial cells. This study was designed to translate these findings to human disease by determining the impact of carrageenan ingestion on clinical manifestations of ulcerative colitis. The investigation is a placebo-controlled, double-blind clinical trial of the carrageenan-free diet in adult patients with ulcerative colitis (UC) who have been in remission for at least one month. All participants must have biopsy-proven ulcerative and have required steroids to enter remission. Participants are randomized to either placebo or carrageenan-containing capsules. They are instructed in the carrageenan-free diet at entry and complete the SCCAI and the SIBDQ questionnaires every two weeks, in order to assess disease severity and identify early sign of relapse. The major study endpoint is interval to relapse, defined as an increase in two or more points on the SCCAI with an increase in medications for UC. Blood samples are collected at entry and every three months to measure inflammatory mediators, including IL-8, IL-6, and TNFα, and to obtain leukocytes for measurements of NFκB and BCL10 content. Stool samples are collected for fecal calprotectin. Samples are compared between placebo and CGN-groups and longitudinally for each patient. Recruitment has been slow for several reasons, including reluctance to make dietary changes, concern about inducing a flare in stable disease, and general wariness about participation in a clinical trial. Results from patient samples will be presented.
a Principal Investigator