Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial

Chen Sarbagili Shabat, Franco Scaldaferri, Eran Zittan, Ayal Hirsch, Maria Chiara Mentella, Tania Musca, Nathaniel Aviv Cohen, Yulia Ron, Naomi Fliss Isakov, Jorge Pfeffer, Michal Yaakov, Caterina Fanali, Laura Turchini, Luca Masucci, Gianluca Quaranta, Nitzan Kolonimos, Anastasia Godneva, Adina Weinberger, Uri Kopylov, Arie Levine, Nitsan Maharshak, Chen Sarbagili Shabat, Franco Scaldaferri, Eran Zittan, Ayal Hirsch, Maria Chiara Mentella, Tania Musca, Nathaniel Aviv Cohen, Yulia Ron, Naomi Fliss Isakov, Jorge Pfeffer, Michal Yaakov, Caterina Fanali, Laura Turchini, Luca Masucci, Gianluca Quaranta, Nitzan Kolonimos, Anastasia Godneva, Adina Weinberger, Uri Kopylov, Arie Levine, Nitsan Maharshak

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.

Keywords: Ulcerative colitis; diet; faecal transplantation; fibre; microbiome.

© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.

Figures

Figure 1.
Figure 1.
Trial design.
Figure 2.
Figure 2.
Participant flow diagram.
Figure 3.
Figure 3.
Clinical response, clinical remission, and endoscopic remission at Week 8 by intention to treat.
Figure 4.
Figure 4.
Remission versus deterioration at Week 8 by group [intention to treat].

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