ReviewAntibiotics (Basel, Switzerland)2022
SER-109: An Oral Investigational Microbiome Therapeutic for Patients with Recurrent
Review in Antibiotics (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Enabling Clinical Translation of Oral Probiotics Through Formulation Engineering and Scalable Manufacturing.Biotechnology journal · 2026Pooled it
- Alternative treatment of recurrentFrontiers in microbiology · 2024Pooled it
- Microbiome and Metabolome Restoration After Administration of Fecal Microbiota, Live-jslm (REBYOTA) for Preventing Recurrent Clostridioides difficile Infection.The Journal of infectious diseases · 2025Trial
- Safety and Efficacy of Fecal Microbiota, Live-jslm, in Preventing RecurrentOpen forum infectious diseases · 2025Trial
- Transplantation of encapsulated fecal microbiota: research progress and future trends.World journal of pediatrics : WJP · 2026Review
- Butyrate-Producing Bacteria in Intestinal Disease Therapy: Potential and Challenges.Biotechnology journal · 2026Review
- The microbial metabolome: remodeling the therapeutic landscape in hematologic malignancies.NPJ biofilms and microbiomes · 2026Review
- Successful fecal microbiota transplants in post-antibiotic treated recurrentGut microbes reports · 2026Article
- Translating priority effects and niche engineering into rational microbiome therapeutics across the gut-lung axis.Frontiers in microbiology · 2026Review
- Design and application of synthetic human gut microbial communities.Gut microbes · 2025Review
- CRISPR-engineered microbiome: living therapeutics revolutionize blood cancer immunotherapy.NPJ biofilms and microbiomes · 2025Review
- Successful Fecal Microbiota Transplants in Post-antibiotic Treated RecurrentResearch square · 2025Article
- C. difficile Infection in Colorectal Cancer: Risk Determinants, Outcomes, and Evolving Management Approaches.Journal of gastrointestinal cancer · 2025Review
- Article
- Risk factors and outcomes of Clostridioides difficile infection in patients with colorectal cancer: critical perspective in management.Gut pathogens · 2025Review
- Microbiome, Potential Therapeutic Agents: New Players of Obesity Treatment.Journal of microbiology and biotechnology · 2025Review
- Clinical translation of microbiome research.Nature medicine · 2025Review
- The Future of Microbiome Therapeutics.Drugs · 2025Review
- Patient Satisfaction Scale Following a Laxative for Antibiotic Washout Prior to Oral Microbiome Therapy.Advances in therapy · 2025Article
- Bacterial live therapeutics for human diseases.Molecular systems biology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 8 institutions in 3 countries.
Funding
Abstract
Clostridioides difficile infection (CDI) is classified as an urgent health threat by the Centers for Disease Control and Prevention (CDC), and affects nearly 500,000 Americans annually. Approximately 20−25% of patients with a primary infection experience a recurrence, and the risk of recurrence increases with subsequent episodes to greater than 40%. The leading risk factor for CDI is broad-spectrum antibiotics, which leads to a loss of microbial diversity and impaired colonization resistance. Current FDA-approved CDI treatment strategies target toxin or toxin-producing bacteria, but do not address microbiome disruption, which is key to the pathogenesis of recurrent CDI. Fecal microbiota transplantation (FMT) reduces the risk of recurrent CDI through the restoration of microbial diversity. However, FDA safety alerts describing hospitalizations and deaths related to pathogen transmission have raised safety concerns with the use of unregulated and unstandardized donor-derived products. SER-109 is an investigational oral microbiome therapeutic composed of purified spore-forming Firmicutes. SER-109 was superior to a placebo in reducing CDI recurrence at Week 8 (12% vs. 40%, respectively; p < 0.001) in adults with a history of recurrent CDI with a favorable observed safety profile. Here, we discuss the role of the microbiome in CDI pathogenesis and the clinical development of SER-109, including its rigorous manufacturing process, which mitigates the risk of pathogen transmission. Additionally, we discuss compositional and functional changes in the gastrointestinal microbiome in patients with recurrent CDI following treatment with SER-109 that are critical to a sustained clinical response.
Indexed as
Identifiers
What OpenQuestion holds
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.