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Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial
Open accessAbstract
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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“However, dietary priming of donors was not effective in improving the FMT success in patients with UC. 113”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [113]
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Metadata
- 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
- ORCID
- Venue
- Journal of Crohn s and Colitis
- Publisher
- Oxford University Press (OUP)
- Published
- 2021-09-13
- Volume
- 16
- Issue
- 3
- Pages
- 369-378
- ISSN
- 1873-9946 (ISSN-L)
- 1876-4479
- PMC
- PMC8919830
- 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
- hybrid
- doi.org
- Licence
- 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
- Health Sciences › Medicine › Gastroenterology › 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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