Abstract

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 2Franco Scaldaferri 3 4Eran Zittan 5Ayal Hirsch 2 6Maria Chiara Mentella 7Tania Musca 7Nathaniel Aviv Cohen 6Yulia Ron 6Naomi Fliss Isakov 2 6Jorge Pfeffer 6Michal Yaakov 1Caterina Fanali 4Laura Turchini 4Luca Masucci 8 9Gianluca Quaranta 8 9Nitzan Kolonimos 5Anastasia Godneva 10Adina Weinberger 10Uri Kopylov 2 11Arie Levine 1 2Nitsan Maharshak 2 6

 
     

Author information

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.

Abstract

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.

 

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