P-198 YI Comparative Analysis of the Efficacy of Fecal Transplantation in Pediatric Inflammatory Bowel Disease Patients with and Without Clostridium Difficile Infection

Abstract

Background: Current evidence suggests that inflammatory bowel disease (IBD) results from an aberrant immune reaction to gut bacterial antigens. Patients with IBD have been shown to have an altered microbial diversity resulting in dysbiosis, which could be a cause or result of gut inflammation. Oftentimes, IBD patients presenting with a flare are found to be positive for Clostridium difficile infection (CDI) that may be due to colonization versus CDI-related colitis. There is still a paucity of data on the role of fecal microbiome transplantation (FMT) in IBD therapy. Despite the abundant literature on the superiority of FMT for the treatment of primary recurrent CDI (RCDI), its efficacy in treatment of IBD flares with concurrent RCDI has not yet been established. We report a comparative analysis of the efficacy of FMT in pediatric IBD patients with and without RCDI. Methods: The aim of this study was to compare the efficacy of FMT between 2 cohorts of patients: IBD patients who were found to have RCDI while having a disease flare (CDI+) and IBD patients with a flare but were negative for CDI (CDI2). CDI+ patients who received FMT as a part of their clinical care were retrospectively reviewed for CDI resolution and IBD flare response. Response was defined as clinical resolution of IBD flare symptoms. CDI2 patients were prospectively studied as a part of a clinical trial on the safety and efficacy of FMT (NCT02108821). Response was defined as an improvement in the Pediatric Ulcerative Colitis Activity Index (PUCAI) by 15 points or in the Pediatric Crohn's Disease Activity Index (PCDAI) by 12.5 points and/or a normalization of elevated fecal calprotectin markers. The screening criteria for the recipient and donor as well the FMT protocol in both groups was similar. All patients were followed for a minimum of 6 months. Results: Thirty patients with IBD (age range 1-21 years; median 14) who received 33 FMTs for disease flare with and without RCDI were included. Twenty-one CDI+ patients received a total of 24 FMTs, of which 12 were by nasojejunal, 7 by colonoscopic alone, and 5 by both endoscopic and colonoscopic routes. Three CDI+ patients received 2 FMTs each. Of the 24 FMTs in CDI+ group, 18 had enduring resolution, 3 failed to resolve CDI, and 3 had relapsed CDI within a 6-month period. Nine CDI- patients received a single FMT by both endoscopy and colonoscopy except for one patient who received by colonoscopy alone. Initial response at 1 month was observed in 62% (13/21) and 67% (6/9) of CDI+ and CDI2 patients, respectively. By 6 months, only 43% (9/21) of CDI+ and 22% (2/9) of CDI2 patients maintained their response. Though the numbers were small, there was no significant difference in the response rates between the 2 groups (1 month P = 1; 6 month P = 0.42). Conclusions: There was a trend toward higher resolution of IBD flare in CDI+ patients than in CDI- patients, though it did not achieve statistical significance. Further prospective, randomized trials may be warranted in a larger population.