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Randomized Controlled Trial
. 2022 Mar 14;16(3):369-378.
doi: 10.1093/ecco-jcc/jjab165.

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

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
Affiliations
Randomized Controlled Trial

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

Chen Sarbagili Shabat et al. J Crohns Colitis. .

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.

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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].
See this image and copyright information in PMC

Comment in

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