Evidence map›Paper›PMID 24762631›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2014

Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study.

Ilan Youngster, Jenny Sauk, Christina Pindar, Robin G Wilson, Jess L Kaplan, Mark B Smith, Eric J Alm, Dirk Gevers, George H Russell, Elizabeth L Hohmann

3 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 211 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
211citing papers in PubMed, 12 pooled it
36.0field-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.

NCT01704937 phase1completednot on this map

Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum

TypeinterventionalSponsorMassachusetts General HospitalRan2012 to 2014Enrolled20ConditionsClostridium Difficile InfectionArmsFecal Microbiota Transplant (FMT)
NCT02255305 phase2terminatednot on this mapstarted 2015, after this paper: background citation

Fecal Microbiota Transplantation Versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium Difficile Infection

TypeinterventionalSponsorEndeavor HealthRan2015 to 2020Enrolled6ConditionsClostridium Difficile InfectionArmsFMT, Antimicrobials
NCT04960306 phase3unknown statusnot on this mapstarted 2023, after this paper: background citation

Fecal Filtrate Versus Conventional Microbiota Transplantation in the Treatment of Multiple Recurrent Clostridioides Difficile Infection (FILTRATE): A Protocol of a Randomized, Controlled Trial

TypeinterventionalSponsorUniversity of PecsRan2023 to 2025Enrolled238ConditionsClostridium Difficile Infection, Recurrent Clostridium Difficile InfectionArmsFecal filtrate transplantation, Conventional fecal microbiota transplantation
3 · Its place in the literature

Who cites it

211 citing papers in PubMed, 12 syntheses or guidelines pooled it, 478 citations in OpenAlex.

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  8. Fecal transplantation for treatment of inflammatory bowel disease.The Cochrane database of systematic reviews · 2018
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151 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

10 authors at 3 institutions in 1 country.

Ilan YoungsterDivision of Infectious Diseases, Massachusetts General Hospital.
Jenny Sauk
Christina Pindar
Robin G Wilson
Jess L Kaplan
Mark B Smith
Eric J Alm
Dirk Gevers
George H Russell
Elizabeth L Hohmann
Massachusetts General Hospital · USHarvard University · USBroad Institute · US

Funding

Pilot & Feasibility ProgramP30DK043351 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI RAYMOND T CHUNG · 1991 to 2026
$35.3M
Harvard Clinical and Translational Science Center (UL1)UL1TR000170 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2012 to 2013
$31.4M
NCATS NIH HHS 8UL1TR000170-05NCATS NIH HHS UL1 TR000170NIAID NIH HHS HHSN272200900018CNIDDK NIH HHS P30 DK043351
6 · The paper itself

Abstract

backgroundRecurrent Clostridium difficile infection (CDI) with poor response to standard antimicrobial therapy is a growing medical concern. We aimed to investigate the outcomes of fecal microbiota transplant (FMT) for relapsing CDI using a frozen suspension from unrelated donors, comparing colonoscopic and nasogastric tube (NGT) administration.

methodsHealthy volunteer donors were screened and a frozen fecal suspension was generated. Patients with relapsing/refractory CDI were randomized to receive an infusion of donor stools by colonoscopy or NGT. The primary endpoint was clinical resolution of diarrhea without relapse after 8 weeks. The secondary endpoint was self-reported health score using standardized questionnaires.

resultsA total of 20 patients were enrolled, 10 in each treatment arm. Patients had a median of 4 (range, 2-16) relapses prior to study enrollment, with 5 (range, 3-15) antibiotic treatment failures. Resolution of diarrhea was achieved in 14 patients (70%) after a single FMT (8 of 10 in the colonoscopy group and 6 of 10 in the NGT group). Five patients were retreated, with 4 obtaining cure, resulting in an overall cure rate of 90%. Daily number of bowel movements changed from a median of 7 (interquartile range [IQR], 5-10) the day prior to FMT to 2 (IQR, 1-2) after the infusion. Self-ranked health score improved significantly, from a median of 4 (IQR, 2-6) before transplant to 8 (IQR, 5-9) after transplant. No serious or unexpected adverse events occurred.

conclusionsIn our initial feasibility study, FMT using a frozen inoculum from unrelated donors is effective in treating relapsing CDI. NGT administration appears to be as effective as colonoscopic administration. CLINICAL TRIALS REGISTRATION: NCT01704937.

Indexed as

AdolescentAdultAgedAged, 80 and overBiological TherapyChildClostridioides difficileClostridium InfectionsColonoscopyDiarrheaFemaleHumansIntubation, GastrointestinalMaleMiddle AgedPilot ProjectsClostridium difficilefecal microbiota transplantfrozen inoculummicrobiome

Identifiers

PMID24762631
PMCPMC4017893
OpenAlexW2146116383

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.