Cited by 110Inflammatory Bowel DiseaseAnorectal Disease Treatments and OutcomesGut microbiota and health

Use of faecal transplantation with a novel diet for mild to moderate active ulcerative colitis: the CRAFT UC randomised controlled trial

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Sarbagili Shabat, Chen, Scaldaferri, Franco, Zittan, Eran, Hirsch, Ayal, Mentella, Maria Chiara, Musca, Tania, Cohen, Nathaniel Aviv, Ron, Yulia +13 more·2022·Journal of Crohn s and 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.

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Authors
Sarbagili Shabat, C., Scaldaferri, F., Zittan, E., Hirsch, A., Mentella, M. C., Musca, T., Cohen, N. A., Ron, Y., Fliss Isakov, N., Pfeffer, J., Yaakov, M., Fanali, C., Turchini, L., Masucci, L., Quaranta, G., Kolonimos, N., Godneva, A., Weinberger, A., Kopylov, U., Levine, A., & Maharshak, N.
Affiliations
  • Pediatric Gastroenterology Unit, PIBD Research Center, Wolfson Medical Center, Holon, Israel
  • Università Cattolica del Sacro Cuore (IT)
  • Emek Medical Center (IL)
  • Tel Aviv University (IL)
  • Tel Aviv Sourasky Medical Center (IL)
  • Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
  • Wolfson Medical Center (IL)
  • Agostino Gemelli University Polyclinic (IT)
  • Weizmann Institute of Science (IL)
Corresponding author
Levine, Arie
Venue
Journal of Crohn s and Colitis
Published
2021-09-13
Volume
16
Issue
3
Pages
369-378
ISSN
  • 1873-9946 (ISSN-L)
  • 1876-4479
OpenAlex
W3199218760
Cited by
110
References
30
Citations by year
2026: 16 · 2025: 29 · 2024: 21 · 2023: 31 · 2022: 12 · 2021: 1
FWCI
9.19
Type
journal article
Language
en
Open access
Locations
  • Journal of Crohn s and Colitis (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • PubliCatt (Università Cattolica del Sacro Cuore) (submittedVersion, other-oa)
Funders
Azrieli Foundation
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
  • Health Sciences › Medicine › Surgery › Anorectal Disease Treatments and Outcomes
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
Keywords
ulcerative colitis
MeSH terms
Fecal Microbiota Transplantation, Adult, Colitis, Ulcerative, Colonoscopy, Diet, Humans, Remission Induction

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