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

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.