Evidence map›Paper›PMID 37256213›Full record

ArticleOpen forum infectious diseases2023

Retrospective Analysis of the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA

Paul Feuerstadt, Adam Harvey, David S Yoho, Julia B Garcia-Diaz, Whitfield L Knapple, Lindy Bancke

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.3field-weighted citation impact, top 7% 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

9 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Newer Therapeutics to Selectively KillInfectious disease reports · 2026
    Review
  3. Review
  4. Article
  5. Safety and effectiveness of fecal microbiota, live-jslm (REBYOTATherapeutic advances in gastroenterology · 2025
    Article
  6. Prevention of recurrentTherapeutic advances in gastroenterology · 2025
    Article
  7. Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTATherapeutic advances in gastroenterology · 2024
    Article
  8. Review
  9. Review
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

6 authors at 3 institutions in 1 country.

Paul FeuerstadtYale University School of Medicine; PACT Gastroenterology Center, Hamden, Connecticut, USA.
Adam HarveyRebiotix (a Ferring Company), Roseville, Minnesota, USA.
David S YohoDepartment of Gastroenterology, Mid-Atlantic Permanente Medical Group, Springfield, Virginia, USA.
Julia B Garcia-DiazDepartment of Clinical Infectious Diseases Research and Medical Subspecialties, Ochsner Medical Center, New Orleans, Louisiana, USA.
Whitfield L KnappleDepartment of Gastroenterology, Arkansas Gastroenterology, North Little Rock, Arkansas, USA.
Lindy BanckeRebiotix (a Ferring Company), Roseville, Minnesota, USA.
Arkansas Cardiology · USOchsner Medical Center · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

Background: Fecal microbiota, live-jslm (RBL; REBYOTA™), the first microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent recurrent Methods: We retrospectively identified adults with rCDI treated with RBL under enforcement discretion between November 1, 2015, and September 30, 2019, across 5 study sites. CDI diagnosis was based on site-specific practice. The primary safety set (PSS) included all patients who were naïve to previous RBL treatment and had continuously comprehensive medical records for 6 months following treatment. Results: The primary treatment cohort had 94 patients; the PSS included 64 patients with common comorbidities receiving diverse chronic therapeutics. Most treatment-emergent adverse events were mild to moderate in severity and comparable between comorbidity subgroups and the overall population. There were no serious adverse events related to RBL or the administration procedure. In the PSS, 82.8% of RBL-treated patients responded at 8 weeks, of whom 88.7% had sustained response through 6 months. The number of RBL doses administered had no marked effect on outcome. Conclusions: Together with prospective clinical trial outcomes, these findings support the efficacy and safety of RBL to prevent rCDI, with diagnostics and comorbidities representative of real-world clinical practice.

Indexed as

Clostridioides difficilegeneral practiceimmunosuppressioninflammatory bowel disease

Identifiers

PMID37256213
PMCPMC10225279
OpenAlexW4362469394

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.