Evidence map›Paper›PMID 34514495›Full record

Trial reportJournal of Crohn's & colitis2022

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 and 11 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 64 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 11 pooled it
7.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02734589 naterminatednot on this map

Fecal Transplantation Using a Novel Conditioning Method for Donor and Recipient in Mild to Moderate Treatment Refractory Colitis in Inflammatory Bowel Disease

TypeinterventionalSponsorWolfson Medical CenterRan2017 to 2020Enrolled54ConditionsUlcerative ColitisArmsFecal transplantation, Unique novel Diet for UC and Unique novel Diet for the donor + FMT, Unique novel Diet for UC
NCT05791487 narecruitingnot on this mapstarted 2023, after this paper: background citation

Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial

TypeinterventionalSponsorWolfson Medical CenterRan2023 to 2026Enrolled90ConditionsUlcerative Colitis, Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic ModerateArmsUlcerative colitis Exclusion Diet, Partial enteral nutrition (PEN), free diet, Oral Budesonide
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 11 syntheses or guidelines pooled it, 95 citations in OpenAlex.

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  14. Fecal Microbiota Transplantation BeyondJournal of Korean medical science · 2026
    Review
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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 7 institutions in 2 countries.

Chen Sarbagili ShabatPediatric Gastroenterology Unit, PIBD Research Center, Wolfson Medical Center, Holon, Israel.
Franco ScaldaferriDipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore - Fondazione Policlinico 'A. Gemelli' IRCCS, Rome, Italy.ORCID 0000-0001-8334-7541
Eran ZittanGastroenterology Institute, IBD Unit, Haemek Medical Center, Afula, Israel.
Ayal HirschSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Maria Chiara MentellaUOC di Nutrizione Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Tania MuscaUOC di Nutrizione Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Nathaniel Aviv CohenDepartment of Gastroenterology and Hepatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Yulia RonDepartment of Gastroenterology and Hepatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Naomi Fliss IsakovSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Jorge PfefferDepartment of Gastroenterology and Hepatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Michal YaakovPediatric Gastroenterology Unit, PIBD Research Center, Wolfson Medical Center, Holon, Israel.
Caterina FanaliCemad [CENTER for Digestive Disease], UOC Medicina Interna e Gastroenterologia, Fondazione Policlinico 'A. Gemelli' IRCCS, Rome, Italy.
Laura TurchiniCemad [CENTER for Digestive Disease], UOC Medicina Interna e Gastroenterologia, Fondazione Policlinico 'A. Gemelli' IRCCS, Rome, Italy.ORCID 0000-0002-1999-5146
Luca MasucciIstituto di Microbiologia, Università Cattolica del Sacro Cuore - Fondazione Policlinico 'A. Gemelli' IRCSS, Rome, Italy.
Gianluca QuarantaIstituto di Microbiologia, Università Cattolica del Sacro Cuore - Fondazione Policlinico 'A. Gemelli' IRCSS, Rome, Italy.
Nitzan KolonimosGastroenterology Institute, IBD Unit, Haemek Medical Center, Afula, Israel.
Anastasia GodnevaDepartment of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.
Adina WeinbergerDepartment of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, Israel.
Uri KopylovSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Arie LevinePediatric Gastroenterology Unit, PIBD Research Center, Wolfson Medical Center, Holon, Israel.
Nitsan MaharshakSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Tel Aviv University · ILUniversità Cattolica del Sacro Cuore · ITTel Aviv Sourasky Medical Center · ILAgostino Gemelli University Polyclinic · ITEmek Medical Center · ILWeizmann Institute of Science · ILWolfson Medical Center · IL

Funding

Azrieli Foundation
6 · The paper itself

Abstract

backgroundWe 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].

methodsThis 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.

resultsOf 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].

conclusionsUCED 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.

Indexed as

Colitis, UlcerativeFecal Microbiota TransplantationAdultColonoscopyDietHumansRemission Inductiondietfaecal transplantationfibremicrobiomeUlcerative colitis

Identifiers

PMID34514495
PMCPMC8919830
OpenAlexW3199218760

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.