Evidence map›Paper›PMID 39863610›Full record

Trial reportNature communications2025

Fecal microbiota transplantation to prevent acute graft-versus-host disease: pre-planned interim analysis of donor effect.

Swetha Reddi, Liliia Senyshyn, Maryam Ebadi, Daniel Podlesny, Samuel S Minot, Ted Gooley, Amanda J Kabage, Geoffrey R Hill, Stephanie J Lee, Alexander Khoruts and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06026371 (Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation), which is not on this map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT06026371 phase2active not recruitingnot on this map

Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

TypeinterventionalSponsorFred Hutchinson Cancer CenterRan2023 to 2027Enrolled157ConditionsAcute Graft Versus Host Disease, Hematopoietic and Lymphatic System NeoplasmArmsFecal Microbiota Transplantation Capsule, Placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Review
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  9. Gut microbiota in health and disease.Molecular biomedicine · 2026
    Review
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  18. Recent advances in the positive role ofFrontiers in immunology · 2026
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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

11 authors.

Swetha ReddiDepartment of Internal Medicine, University of Washington, Seattle, WA, USA.
Liliia SenyshynClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Maryam EbadiDepartment of Radiation Oncology, University of Washington, Seattle, WA, USA.
Daniel PodlesnyEuropean Molecular Biology Laboratory (EMBL), Heidelberg, Germany.ORCID http://orcid.org/0000-0002-5685-0915
Samuel S MinotData Core, Shared Resources, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-1639-3905
Ted GooleyClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Amanda J KabageDivision of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.ORCID http://orcid.org/0000-0003-3519-7416
Geoffrey R HillTranslational Science and Therapeutics Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Stephanie J LeeClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-2600-6390
Alexander KhorutsDivision of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.ORCID http://orcid.org/0000-0002-3205-3188
Armin RashidiClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA. arashidi@fredhutch.org.ORCID http://orcid.org/0000-0002-9384-272X

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Eric Collisson · 1985 to 2026
$296.4M
Leukemia and Lymphoma Society (Leukemia & Lymphoma Society) ACT9016-24NCI NIH HHS P30 CA015704
6 · The paper itself

Abstract

Gut microbiota disruptions after allogeneic hematopoietic cell transplantation (alloHCT) are associated with increased risk of acute graft-versus-host disease (aGVHD). We designed a randomized, double-blind placebo-controlled trial to test whether healthy-donor fecal microbiota transplantation (FMT) early after alloHCT reduces the incidence of severe aGVHD. Here, we report the results from the single-arm run-in phase which identified the best of 3 stool donors for the randomized phase. The primary and key secondary endpoints were microbiota engraftment and severe aGVHD, respectively. Three cohorts of patients (20 total) received FMT, each from a different donor. FMT was safe and effective in restoring microbiota diversity and commensal species. Microbiota engraftment, determined from shotgun sequencing data, correlated with larger microbiota compositional shifts toward donor and better clinical outcomes. Donor 3 yielded a median engraftment rate of 66%, higher than donors 1 (P = 0.02) and 2 (P = 0.03) in multivariable analysis. Three patients developed severe aGVHD; all 3 had received FMT from donor 1. Donor 3 was selected as the sole donor for the randomized phase. Our findings suggest a clinically relevant donor effect and demonstrate feasibility of evidence-based donor selection. FMT is a holistic microbiota restoration approach that can be performed as a precision therapeutic. ClinicalTrials.gov identifier NCT06026371.

Indexed as

Fecal Microbiota TransplantationGastrointestinal MicrobiomeGraft vs Host DiseaseHematopoietic Stem Cell TransplantationAcute DiseaseAdultDouble-Blind MethodFecesFemaleHumansMaleMiddle AgedTissue DonorsTransplantation, HomologousTreatment OutcomeYoung Adult

Identifiers

PMID39863610
PMCPMC11762788

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.