Lay Summary
Proposal No. IBD-0162R
Principal Investigator: Michael T. Clandinin, Ph.D.
Applicant Organization: University of Alberta (Edmonton, Canada)
Project Title: Milk-derived gangliosides as novel anti-inflammatory therapy for inflammatory bowel disease
Period of Award: March 1, 2006 – August 31, 2008
Gangliosides (GG) are glycosphingolipids that provide important health benefits. GG occur naturally in human and bovine milk. Research conducted in animals suggests that GG influence intestinal function by preventing inflammation in healthy gut and reducing the inflammatory response in diseased gut. These data points to a specific therapeutic role for dietary GG in the prevention and treatment of inflammatory conditions of the gut.
GG may offer an effective therapeutic option for individuals suffering from Crohn’s disease (CD) and ulcerative colitis (UC), the two most common forms of inflammatory bowel disease (IBD). Medications such as steroids that are used to treat IBD patients are not effective for everyone and have many harmful side effects. Dietary GG do not appear to have adverse side effects and may offer protection against some of the harmful side effects of other IBD therapies. GG may therefore be useful alone or in combination with current therapies to augment their therapeutic benefit while minimizing harmful side effects. Evidence indicates that GG also help to maintain the integrity and function of the healthy gut and therefore dietary GG may be uniquely used to both treat and prevent the development of IBD.
Specific dietary supplementation of GG for the treatment of disease has never been attempted in humans and potential health benefits have not been studied. Our objective is to conduct a small study in humans to demonstrate that GG are an effective therapy for individuals with IBD. Research subjects will be divided into two groups, one group will receive 5-ASA plus a placebo and the other will receive 5-ASA plus GG. We will measure disease activity, markers of inflammation, intestinal permeability and lipids in these individuals after eight weeks of therapy. We expect that individuals who receive conventional therapy plus GG will have less severe disease and less intestinal inflammation at the end of eight weeks than individuals who receive conventional therapy with placebo.
If favorable outcomes are obtained, this study will serve as the basis for larger studies in humans to test the usefulness of GG supplementation and to determine how GG act in the body. The results of this study are expected to significantly impact the lives of individuals with IBD by providing evidence in support of the use of a novel, efficacious and non-toxic therapeutic option for individuals affected by IBD.