Scientific Abstract
Proposal No. IBD-0258R
Principal Investigator: Amy Brown, Ph.D., R.D.
Applicant Organization: University of
Project Title: The relationship of a “Crohn’s disease diet” in reducing symptoms of Crohn’s disease, improving quality of life, and decreasing related health care costs
Period of Award: December 1, 2008 – November 30, 2011
Purpose: This pilot clinical trial will determine whether a newly developed “Crohn’s Disease Diet” in the form of an ‘elimination diet,’ derived from evidence-based Medline research, is an effective complementary treatment for Crohn’s disease. Our preliminary Medline review article on 1000+ articles investigated the various dietary substances relating diet to Crohn’s disease, and we have combined them into a balanced “Crohn’s Disease Diet.”
Methods: This 16-week study will be a randomized, single-blinded, placebo-controlled, pilot study of 60 adult patients (18-75 yrs) recruited from Dr. Robert V. Jao’s office, other gastroenterologists, the Crohn’s and Colitis Foundation of America, and the general public through flyers and newspaper stories. These sixty (60) patients, with a mild or moderate Crohn’s Disease Activity Index (CDAI) of 150-450, agree not to be on any other major treatments, with the exception of consistent/stable doses of 5ASA drugs/other medications during the course of the study and will obtain their physician’s permission. They will be divided into a treatment and placebo group: thirty (30) patients will be on the “Crohn’s Disease Diet” (primarily an “anti-inflammatory diet that is an elimination diet - gluten-free, casein-free based with limited carbohydrate) and thirty (30) patients will be given the Dietary Guideline recommendations and similar dietary counseling attention. To assess the clinical efficacy and tolerance of the trial population, patients will be monitored weekly by the PI and research assistant, and have two physician visits (0 and 12 weeks) by a gastroenterologist followed by visits with the PI at 6, 12, and 16 weeks (1-month follow-up) for blood and dietary data collection. Clinical endpoints will be Crohn’s disease Activity Index (CDAI) scores, C-Reactive Protein (CRP) values, fecal calprotectin, sedimentation rate, possibly interleukin-6 , Overall Quality of Life (QOL) through the Inflammatory Bowel Disease Questionnaire (IBDQ) survey, and health care costs measured by a health care cost questionnaire. Statistical analysis will consist of the Student t-test to determine significances for both pre- and post-tests between the two groups in terms of CDAI scores. The Chi-square test will be used to test if the remission rate in the treatment group is significantly different (.05) than the control group. Other tests include non-parameteric Mann-Whitney, and Wilcoxon where appropriate.