- Fecal Incontinence
|Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial
J Crohns Colitis. 2022 Mar 14;16(3):369-378.doi: 10.1093/ecco-jcc/jjab165.
Chen Sarbagili Shabat 1 2, Franco Scaldaferri 3 4, Eran Zittan 5, Ayal Hirsch 2 6, Maria Chiara Mentella 7, Tania Musca 7, Nathaniel Aviv Cohen 6, Yulia Ron 6, Naomi Fliss Isakov 2 6, Jorge Pfeffer 6, Michal Yaakov 1, Caterina Fanali 4, Laura Turchini 4, Luca Masucci 8 9, Gianluca Quaranta 8 9, Nitzan Kolonimos 5, Anastasia Godneva 10, Adina Weinberger 10, Uri Kopylov 2 11, Arie Levine 1 2, Nitsan Maharshak 2 6
1Pediatric Gastroenterology Unit, PIBD Research Center, Wolfson Medical Center, Holon, Israel.
2Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
3Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore - Fondazione Policlinico 'A. Gemelli' IRCCS, Rome, Italy.
4Cemad [CENTER for Digestive Disease], UOC Medicina Interna e Gastroenterologia, Fondazione Policlinico 'A. Gemelli' IRCCS, Rome, Italy.
5Gastroenterology Institute, IBD Unit, Haemek Medical Center, Afula, Israel.
6Department of Gastroenterology and Hepatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
7UOC di Nutrizione Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
8Istituto di Microbiologia, Università Cattolica del Sacro Cuore - Fondazione Policlinico 'A. Gemelli' IRCSS, Rome, Italy.
9Dipartimento Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
10Department of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.
11Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Israel.
Background: We evaluated whether integration of novel diets for donors and patients, in addition to faecal transplantation [FT], could increase FT remission rate in refractory ulcerative colitis [UC].
Methods: This was a blinded, randomised, 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 1and 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 endpoint 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%] vs 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: UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board.