Trial reportThe Journal of infectious diseases2025
Microbiome and Metabolome Restoration After Administration of Fecal Microbiota, Live-jslm (REBYOTA) for Preventing Recurrent Clostridioides difficile Infection.
Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03244644 (A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660), which is not on this map. Cited by 12 papers.
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.
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.
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
Who cites it
12 citing papers in PubMed.
- The impact of an oral purified microbiome therapeutic on the gastrointestinal microbiome.Nature medicine · 2026Trial
- Microbiome compositional changes and clonal engraftment in a phase 3 trial of fecal microbiota, live-jslm for recurrentGut microbes · 2025Trial
- Microbiome-based therapeutics forGut microbes · 2026Review
- Evaluation of fecal microbiota, live (RBL) for the prevention of recurrentJournal of the Canadian Association of Gastroenterology · 2026Article
- Review
- Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies.Infectious diseases and therapy · 2026Review
- Ecological and dietary strategies to constrain Clostridioides difficile.Cell host & microbe · 2026Review
- Newer Therapeutics to Selectively KillInfectious disease reports · 2026Review
- Bile acid dependent attenuation of toxin mediated disease is independent of colonization resistance againstbioRxiv : the preprint server for biology · 2026Article
- Design and application of synthetic human gut microbial communities.Gut microbes · 2025Review
- Decreased Antimicrobial Resistance Gene Richness Following Fecal Microbiota, Live-jslm (REBYOTA®) Administration: Post Hoc Analysis of PUNCH CD3.Open forum infectious diseases · 2025Article
- The evolving landscape of live biotherapeutics in the treatment of Clostridioides difficile infection.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundMicrobiota-based treatments are effective in preventing recurrent Clostridioides difficile infection. Fecal microbiota, live-jslm (REBYOTA; RBL, previously RBX2660) was shown to prevent recurrent C difficile infection in a phase 3 clinical trial (PUNCH CD3) based on a randomized, double-blinded, placebo-controlled design.
methodsStool samples from participants in PUNCH CD3 who received a single blinded dose of rectally administered RBL or placebo were sequenced to determine microbial community composition and calculate the Microbiome Health Index for postantibiotic dysbiosis. The composition of bile acids (BAs) in the same samples was quantified by liquid chromatography-mass spectrometry. Relationships between BA composition and microbiota community structure and correlations with treatment outcomes were assessed.
resultsBefore administration, Gammaproteobacteria and Bacilli dominated the microbiota community, and primary BAs were more prevalent than secondary BAs. Clinical success after administration correlated with shifts to predominantly Bacteroidia and Clostridia, a significant increase in Microbiome Health Index for postantibiotic dysbiosis, and a shift from primary to secondary BAs. Several microbiota and BA changes were more extensive in RBL-treated responders as compared with placebo-treated responders, and microbiota changes correlated with BA changes.
conclusionsClinical response and RBL administration were associated with significant restoration of microbiota and BA composition. CLINICAL TRIALS REGISTRATION: NCT03244644 (https://clinicaltrials.gov/ct2/show/NCT03244644).
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Registered trials
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