Evidence map›Paper›PMID 34238227›Full record

Trial reportBMC gastroenterology2021

Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study.

Jessica W Crothers, Nathaniel D Chu, Le Thanh Tu Nguyen, Magen Phillips, Cheryl Collins, Karen Fortner, Roxana Del Rio-Guerra, Brigitte Lavoie, Peter Callas, Mario Velez and 11 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02390726 (Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis), which is not on this map. Cited by 88 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 11 pooled it
12.7field-weighted citation impact, top 1% 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.

NCT02390726 early_phase1unknown statusnot on this map

Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

TypeinterventionalSponsorUniversity of VermontRan2015 to 2018Enrolled20ConditionsUlcerative Colitis, Active ModerateArmsFecal Microbiota Transplant, Placebo
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 11 syntheses or guidelines pooled it, 120 citations in OpenAlex.

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  20. Fecal Microbiota Transplantation BeyondJournal of Korean medical science · 2026
    Review

28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 5 institutions in 1 country.

Jessica W CrothersDepartment of Pathology and Laboratory Medicine, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT, 05401, USA. Jessica.Crothers@uvmhealth.org.ORCID http://orcid.org/0000-0003-4594-5051
Nathaniel D ChuDepartment of Biological Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA, 02139, USA.
Le Thanh Tu NguyenDepartment of Biological Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA, 02139, USA.
Magen PhillipsDepartment of Medicine, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT, 05401, USA.
Cheryl CollinsDepartment of Medicine, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT, 05401, USA.
Karen FortnerDepartment of Medicine, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT, 05401, USA.
Roxana Del Rio-GuerraFlow Cytometry and Cell Sorting Facility, Department of Surgery, Larner College of Medicine, University of Vermont, 89 Beaumont Ave, Burlington, VT, 05401, USA.
Brigitte LavoieDepartment of Neurological Sciences, Larner College of Medicine, University of Vermont, 89 Beaumont Ave, Burlington, VT, 05401, USA.
Peter CallasDepartment of Medical Biostatistics, University of Vermont, 89 Beaumont Ave, Burlington, VT, 05401, USA.
Mario VelezDepartment of Medicine, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT, 05401, USA.
Aaron CohnDepartment of Medicine, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT, 05401, USA.
Ryan J ElliottOpenBiome, 2067 Massachusetts Ave, Cambridge, MA, 02140, USA.
Wing Fei WongOpenBiome, 2067 Massachusetts Ave, Cambridge, MA, 02140, USA.
Elaine VoFinch Therapeutics, 200 Inner Belt Rd, Somerville, MA, 02143, USA.
Rebecca WilcoxDepartment of Pathology and Laboratory Medicine, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT, 05401, USA.
Mark SmithFinch Therapeutics, 200 Inner Belt Rd, Somerville, MA, 02143, USA.
Zain KassamFinch Therapeutics, 200 Inner Belt Rd, Somerville, MA, 02143, USA.
Ralph BuddDepartment of Medicine, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT, 05401, USA.
Eric J AlmDepartment of Biological Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA, 02139, USA.
Gary M MaweDepartment of Neurological Sciences, Larner College of Medicine, University of Vermont, 89 Beaumont Ave, Burlington, VT, 05401, USA.
Peter L MosesLarner College of Medicine, The University of Vermont, 89 Beaumont Ave, Burlington, VT, 05401, USA.
University of Vermont · USUniversity of Vermont Medical Center · USBroad Institute · USFinch Therapeutics (United States) · USOpenBiome · US

Funding

Using Dengue Controlled Human Infection Model to Identify Adaptive Immune Correlates of ProtectionP20GM125498 · NIGMS · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI Ellen Kozelka · 2018 to 2026
$24.9M
Vermont Immunology/Infectious Diseases CenterP30GM118228 · NIGMS · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI BUDD, RALPH C · 2016 to 2021
$6.8M
Autoimmune mechanisms of gastrointestinal dysmotility in multiple sclerosisR01DK113800 · NIDDK · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI MAWE, GARY M · 2017 to 2020
$1.8M
NIDDK NIH HHS R01 DK113800NIGMS NIH HHS P20 GM125498NIGMS NIH HHS P30 GM118228NIH HHS DK113800NIH HHS P30GM118228
6 · The paper itself

Abstract

backgroundFecal microbiota transplantation (FMT) is a promising new strategy in the treatment of Inflammatory Bowel Disease, but long-term delivery systems are lacking. This randomized study was designed as a safety and feasibility study of long-term FMT in subjects with mild to moderate UC using frozen, encapsulated oral FMT (cFMT).

methodsSubjects were randomized 1:1 to receive FMT induction by colonoscopy, followed by 12 weeks of daily oral administration of frozen encapsulated cFMT or sham therpay. Subjects were followed for 36 weeks and longitudenal clinical assessments included multiple subjective and objective markers of disease severity. Ribosomal 16S bacterial sequencing was used to assess donor-induced changes in the gut microbiota. Changes in T regulatory (Treg) and mucosal associated invariant T (MAIT) cell populations were evaluated by flow cytometry as an exploratory endpoint.

resultsTwelve subjects with active UC were randomized: 6 subjects completed the full 12-week course of FMT plus cFMT, and 6 subjects received sham treatment by colonic installation and longitudinal oral placebo capules. Chronic administration of cFMT was found to be safe and well-tolerated but home storage concerns exist. Protocol adherence was high, and none of the study subjects experienced FMT-associated treatment emergent adverse events. Two subjects that received cFMT achieved clinical remission versus none in the placebo group (95% CI = 0.38-infinity, p = 0.45). cFMT was associated with sustained donor-induced shifts in fecal microbial composition. Changes in MAIT cell cytokine production were observed in cFMT recipients and correlated with treatment response.

conclusionThese pilot data suggest that daily encapsulated cFMT may extend the durability of index FMT-induced changes in gut bacterial community structure and that an association between MAIT cell cytokine production and clinical response to FMT may exist in UC populations. Oral frozen encapsulated cFMT is a promising FMT delivery system and may be preferred for longterm treatment strategies in UC and other chronic diseases but further evaluations will have to address home storage concerns. Larger trials should be done to explore the benefits of cFMT and to determine its long-term impacts on the colonic microbiome.

trial registrationClinicalTrials.gov (NCT02390726). Registered 17 March 2015, https://clinicaltrials.gov/ct2/show/NCT02390726?term=NCT02390726&draw=2&rank=1 .

Indexed as

Colitis, UlcerativeFecal Microbiota TransplantationFecesHumansPilot ProjectsProspective StudiesTreatment OutcomeFecal microbiota transplantationFMTIBDInflammatory bowel diseaseMAIT cellsMicrobiomeMicrobiotaUCUlcerative colitis

Identifiers

PMID34238227
PMCPMC8268596
OpenAlexW3179013051

What OpenQuestion holds

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LicenceCC BY
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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.