Evidence map›Paper›PMID 27547925›Full record

Trial reportAnnals of internal medicine2016

Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial.

Colleen R Kelly, Alexander Khoruts, Christopher Staley, Michael J Sadowsky, Mortadha Abd, Mustafa Alani, Brianna Bakow, Patrizia Curran, Joyce McKenney, Allison Tisch and 3 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of internal medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01703494 (Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection), which is not on this map. Cited by 319 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
319citing papers in PubMed, 6 pooled it
53.8field-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.

NCT01703494 phase2unknown statusnot on this map

Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

TypeinterventionalSponsorColleen KellyRan2012 to 2015Enrolled53ConditionsClostridium DifficileArmsFecal Microbiota Transplantation, Sham Fecal Microbiota Transplantation
3 · Its place in the literature

Who cites it

319 citing papers in PubMed, 6 syntheses or guidelines pooled it, 600 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Trial
  8. Trial
  9. SER-109, an Investigational Microbiome Drug to Reduce Recurrence After Clostridioides difficile Infection: Lessons Learned From a Phase 2 Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
  10. Fecal Microbiota Transplantation BeyondJournal of Korean medical science · 2026
    Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Gut Microbiome Recovery inDiseases (Basel, Switzerland) · 2026
    Article
  17. Review
  18. Review
  19. Review
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Colleen R KellyFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Alexander KhorutsFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Christopher StaleyFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Michael J SadowskyFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Mortadha AbdFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Mustafa AlaniFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Brianna BakowFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Patrizia CurranFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Joyce McKenneyFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Allison TischFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Steven E ReinertFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Jason T MachanFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Lawrence J BrandtFrom Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
Montefiore Medical Center · USAlbert Einstein College of Medicine · USUniversity of Minnesota · USUniversity of Rhode Island · US

Funding

The role of bile acid metabolism recovery in treatment of C. difficile infectionR21AI114722 · NIAID · UNIVERSITY OF MINNESOTA · PI CHEN, CHI, KHORUTS, ALEXANDER · 2015 to 2016
$414k
NIAID NIH HHS R21 AI114722
6 · The paper itself

Abstract

backgroundTo date, evidence for the efficacy of fecal microbiota transplantation (FMT) in recurrent Clostridium difficile infection (CDI) has been limited to case series and open-label clinical trials.

objectiveTo determine the efficacy and safety of FMT for treatment of recurrent CDI.

designRandomized, controlled, double-blind clinical trial. (ClinicalTrials.gov: NCT01703494).

settingTwo academic medical centers. PATIENTS: 46 patients who had 3 or more recurrences of CDI and received a full course of vancomycin for their most recent acute episode.

interventionFecal microbiota transplantation with donor stool (heterologous) or patient's own stool (autologous) administered by colonoscopy. MEASUREMENTS: The primary end point was resolution of diarrhea without the need for further anti-CDI therapy during the 8-week follow-up. Safety data were compared between treatment groups via review of adverse events (AEs), serious AEs (SAEs), and new medical conditions for 6 months after FMT. Fecal microbiota analyses were performed on patients' stool before and after FMT and also on donors' stool.

resultsIn the intention-to-treat analysis, 20 of 22 patients (90.9%) in the donor FMT group achieved clinical cure compared with 15 of 24 (62.5%) in the autologous FMT group (P = 0.042). Resolution after autologous FMT differed by site (9 of 10 vs. 6 of 14 [P = 0.033]). All 9 patients who developed recurrent CDI after autologous FMT were free of further CDI after subsequent donor FMT. There were no SAEs related to FMT. Donor FMT restored gut bacterial community diversity and composition to resemble that of healthy donors. LIMITATION: The study included only patients who had 3 or more recurrences and excluded those who were immunocompromised and aged 75 years or older.

conclusionDonor stool administered via colonoscopy seemed safe and was more efficacious than autologous FMT in preventing further CDI episodes. PRIMARY FUNDING SOURCE: National Institute of Diabetes and Digestive and Kidney Diseases.

Indexed as

Clostridioides difficileFecal Microbiota TransplantationClostridium InfectionsColonoscopyDiarrheaDouble-Blind MethodFemaleHumansIntention to Treat AnalysisMaleMiddle AgedProspective StudiesRecurrenceTreatment Outcome

Identifiers

PMID27547925
PMCPMC5909820
OpenAlexW2512704070

What OpenQuestion holds

Textmetadata
LicenceTDM
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.