Background: Diet may be an important factor in the natural history of Crohn’s disease (CD). We sought to determine whether exclusion of red and processed meats reduces the risk of CD relapse in a prospective randomized controlled trial. Methods: Adults with CD were recruited from CCFA Partners, an Internet-based cohort of IBD patients. Individuals who were in remission, defined as abbreviated Crohn’s Disease Activity Index (aCDAI) ≤ 150, on a biannual survey and who reported consumption of red meat at least once weekly were randomized to consume a minimum of 2 servings/week (Arm A) or not more than 1 serving per month (Arm B) of red or processed meat for 48 weeks. Eligible subjects then received an email invitation with a link to a study arm-specific consent. The primary outcome was relapse of CD, defined as increase in aCDAI by 70 points and to >150. The secondary outcome was moderate/severe relapse, defined as an increase in aCDAI to >219 or a need for CD surgery or new CD medication. Results: 659 individuals were randomized of whom 214 consented (n=118 in arm A and n=96 in Arm B). Baseline characteristics were similar in each arm and among those who consented vs. non-participants. Comparison of baseline nutrient intake on Diet History Questionnaire II, using PERMANOVA, showed no differences between the two groups (p=0.152). Adherence to the high meat diet, determined by % weeks consuming 2+ servings of red or processed meat, was 98.5% compared to 57% adherence to the low meat diet . At least a mild relapse occurred in 59% of patients during the study. There were no significant differences in time to overall (Fig 1, p=0.61) or moderate/severe (Fig 2, p=0.50) relapse. Conclusions: In patients with CD in remission, there was no difference in time to relapse in patients assigned to a high vs. low red and processed meat diet, although adherence was only modest in the low meat group.
