Colon to Rectum
J Crohns Colitis. 2022;16(3):369–78
Use of fecal transplantation with a novel diet for mild-to-moderate active ulcerative colitis: The CRAFT UC randomized controlled trial
Background: The authors evaluated whether integration of novel diets for donors and patients, in addition to fecal transplantation (FT), could increase FT remission rate in refractory ulcerative colitis (UC).
Methods: This was a blinded, randomized, controlled trial in adults with active UC, defined by a Simple Clinical Colitis Activity Index (SCCAI) of ≥ 5 and ≤ 11 and endoscopic Mayo score 2–3, refractory to medication. Group 1 received free diet and single donor standard FT by colonoscopy on day 1 and rectal enemas on days 2 and 14 without dietary conditioning of the donor. Group 2 received FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet (UCED) for the patients. Group 3 received the UCED alone. The primary end point was week 8 clinical steroid-free remission, defined as SCCAI < 3.
Results: Of 96 planned patients, 62 were enrolled. Remission week 8 group 1 was 2/17 (11.8%), group 2 was 4/19 (21.1%), group 3 was 6/15 (40%) (non-significant). Endoscopic remission group 1 was 2/17 (12%), group 2 was 3/19 (16%), group 3 was 4/15 (27%) (group 1 vs. 3, p = 0.38). Mucosal healing (Mayo 0) was achieved only in group 3 (3/15, 20%) versus 0/36 FT patients (p = 0.022). Exacerbation of disease occurred in 3/17 (17.6%) of group 1, 4/19 (21.1%) of group 2, and 1/15 (6.7%) of group 3 (group 2 vs. 3, p = 0.35).
Conclusions: Ulcerative Colitis Exclusion Diet alone appeared to achieve higher clinical remission and mucosal healing than single donor fecal transplantation with or without diet. The study was stopped for futility by a safety monitoring board.