Evidence map›Paper›PMID 42286373›Full record

ReviewInfectious diseases and therapy2026

Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies.

Teena Chopra, Daniel Van Handel, Brian Baggott, Robert Orenstein, Kelly Reveles, Beth Guthmueller, Shivam Srivastava, Sahil Khanna

6 registry-linked trialsAbstract readReview
In one paragraph

Review in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT01925417 phase2completednot on this map

A Phase 2 Open-label Clinical Trial Demonstrating the Safety of RBX2660 Microbiota Suspension for the Treatment of Recurrent Clostridium Difficile-associated Diarrhea (CDAD): the PUNCH CD Study

TypeinterventionalSponsorRebiotix Inc.Ran2013 to 2014Enrolled34ConditionsRecurrent Clostridium Difficile InfectionArmsRBX2660 (microbiota suspension)
NCT02299570 phase2completednot on this map

A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection

TypeinterventionalSponsorRebiotix Inc.Ran2014 to 2018Enrolled150ConditionsEnterocolitis Clostridium Difficile RecurrentArmsRBX2660 (microbiota suspension), Placebo
NCT02589847 phase2completednot on this map

An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection

TypeinterventionalSponsorRebiotix Inc.Ran2015 to 2019Enrolled272ConditionsClostridium Difficile InfectionArmsRBX2660, Standard of Care Antibiotics
NCT03244644 phase3completednot on this map

A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection

TypeinterventionalSponsorRebiotix Inc.Ran2017 to 2020Enrolled320ConditionsClostridium Difficile Infection (CDI)ArmsRBX2660, Placebo, Open label RBX2660 (only for confirmed CDI recurrence)
NCT03931941 phase3completednot on this map

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection

TypeinterventionalSponsorRebiotix Inc.Ran2019 to 2023Enrolled793ConditionsClostridium Difficile Infection, Infection, Communicable DiseasesArmsRBX2660
NCT05831189 phase3completednot on this map

A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection

TypeinterventionalSponsorFerring PharmaceuticalsRan2023 to 2025Enrolled41ConditionsClostridium Difficile Infection RecurrenceArmsRBX2660
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

8 authors.

Teena ChopraWayne State University, 4201 St Antoine, UHC-4G, Detroit, MI, 48201, USA. tchopra@med.wayne.edu.ORCID http://orcid.org/0000-0003-1185-4549
Daniel Van HandelMNGI Digestive Health, Minneapolis, MN, USA.
Brian BaggottCleveland Clinic, Cleveland, OH, USA.
Robert OrensteinMayo Clinic, Phoenix, AZ, USA.
Kelly RevelesThe University of Texas at Austin, Austin, TX, USA.ORCID http://orcid.org/0000-0001-8880-4879
Beth GuthmuellerFerring Pharmaceuticals, Inc, Parsippany, NJ, USA.
Shivam SrivastavaFerring Pharmaceuticals A/S, Copenhagen, Denmark.
Sahil KhannaMayo Clinic, Rochester, MN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clostridioides difficile infection (CDI) is one of the most common healthcare-associated infections in the US, and recurrence remains a major clinical challenge, as standard-of-care antibiotics fail to prevent recurrence in up to one-third of cases. Fecal microbiota, live-jslm (RBL) is the first single-dose, microbiota-based product approved by the US Food and Drug Administration and Health Canada for the prevention of recurrent CDI (rCDI) following standard-of-care antibiotics. The RBL clinical development program is the largest to date for any microbiota-based product, encompassing seven studies and enrolling over 1700 participants to evaluate the safety and efficacy of RBL in preventing rCDI. Although the RBL development program consistently evaluated both efficacy and safety outcomes across all studies, this review summarizes the study designs, with a primary focus on the efficacy outcomes. The program consists of randomized controlled trials, open-label cohorts, retrospective analyses, and real-world data, each contributing unique insights across different patient populations and treatment settings. All studies enrolled adults aged ≥ 18 years with rCDI who received antibiotics for their enrolling CDI episode before RBL administration. Most studies administered RBL rectally, except for an open-label study and a retrospective study, which evaluated colonoscopic administration of RBL. Treatment success was evaluated at 8 weeks, and sustained clinical response was evaluated at 6 or 24 months after RBL and/or placebo administration, depending on the study design. Overall, the study designs for all seven studies were consistent, with slight differences between number of CDI episodes (specifically, 2 studies allowed enrollment after the first CDI recurrence), blinding, controls, and administration routes. Efficacy data of RBL reported across all studies consistently demonstrated RBL is efficacious for the prevention of rCDI in a broad adult population.

trial registrationClinicalTrials.gov. NCT01925417; NCT02299570; NCT02589847; NCT03244644; NCT03931941; NCT05831189.

Indexed as

CDIClostridioides difficileEfficacyFecal microbiota, Live-jslm (RBL)Microbiota-based therapyrCDI

Identifiers

PMID42286373
PMCPMC13350609

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.