Evidence map›Paper›PMID 38572716›Full record

Trial reportJournal of Crohn's & colitis2024

Faecal Microbiota Transplantation Engraftment After Budesonide or Placebo in Patients With Active Ulcerative Colitis Using Pre-selected Donors: A Randomized Pilot Study.

Emilie van Lingen, Sam Nooij, Elisabeth M Terveer, Emily Crossette, Amanda L Prince, Shakti K Bhattarai, Andrea Watson, Gianluca Galazzo, Rajita Menon, Rose L Szabady and 7 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
7.4field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

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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

17 authors at 5 institutions in 2 countries.

Emilie van LingenDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
Sam NooijDepartment of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands.
Elisabeth M TerveerDepartment of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands.
Emily CrossetteVedanta Biosciences, Cambridge, MA, USA.
Amanda L PrinceVedanta Biosciences, Cambridge, MA, USA.
Shakti K BhattaraiUniversity of Massachusetts Chan Medical School, Department of Microbiology and Physiological Systems, Worcester, MA, USA.
Andrea WatsonVedanta Biosciences, Cambridge, MA, USA.
Gianluca GalazzoVedanta Biosciences, Cambridge, MA, USA.
Rajita MenonVedanta Biosciences, Cambridge, MA, USA.
Rose L SzabadyVedanta Biosciences, Cambridge, MA, USA.
Vanni BucciUniversity of Massachusetts Chan Medical School, Department of Microbiology and Physiological Systems, Worcester, MA, USA.
Jason M NormanVedanta Biosciences, Cambridge, MA, USA.
C Janneke van der WoudeDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.
Sander van der MarelDepartment of Gastroenterology and Hepatology, Haaglanden Medisch Centrum, den Haag, The Netherlands.
Hein W VerspagetDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
Andrea E van der Meulen-de JongDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
Josbert J KellerDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
Vedantra Pharmaceuticals (United States) · USLeiden University Medical Center · NLUniversity of Massachusetts Chan Medical School · USErasmus MC · NLMedisch Centrum Haaglanden · NL

Funding

Vedanta Biosciences
6 · The paper itself

Abstract

backgroundFaecal microbiota transplantation [FMT] shows some efficacy in treating patients with ulcerative colitis [UC], although variability has been observed among donors and treatment regimens. We investigated the effect of FMT using rationally selected donors after pretreatment with budesonide or placebo in active UC.

methodsPatients ≥18 years old with mild to moderate active UC were randomly assigned to 3 weeks of budesonide [9 mg] or placebo followed by 4-weekly infusions of a donor faeces suspension. Two donors were selected based on microbiota composition, regulatory T cell induction and short-chain fatty acid production in mice. The primary endpoint was engraftment of donor microbiota after FMT. In addition, clinical efficacy was assessed.

resultsIn total, 24 patients were enrolled. Pretreatment with budesonide did not increase donor microbiota engraftment [p = 0.56] nor clinical response, and engraftment was not associated with clinical response. At week 14, 10/24 [42%] patients achieved [partial] remission. Remarkably, patients treated with FMT suspensions from one donor were associated with clinical response [80% of responders, p < 0.05] but had lower overall engraftment of donor microbiota. Furthermore, differences in the taxonomic composition of the donors and the engraftment of certain taxa were associated with clinical response.

conclusionIn this small study, pretreatment with budesonide did not significantly influence engraftment or clinical response after FMT. However, clinical response appeared to be donor-dependent. Response to FMT may be related to transfer of specific strains instead of overall engraftment, demonstrating the need to characterize mechanisms of actions of strains that maximize therapeutic benefit in UC.

Indexed as

BudesonideColitis, UlcerativeFecal Microbiota TransplantationAdultAnti-Inflammatory AgentsDonor SelectionDouble-Blind MethodFecesFemaleGastrointestinal MicrobiomeHumansMaleMiddle AgedPilot ProjectsTreatment OutcomeAnti-Inflammatory AgentsBudesonidefaecal microbiota transplantationinflammatory bowel diseaseMicrobiomeulcerative colitis

Identifiers

PMID38572716
PMCPMC11369067
OpenAlexW4393996497

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.