SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection
Open accessAbstract
BACKGROUND: infection. METHODS: infection recurrence up to 8 weeks after treatment. Diagnosis by toxin testing was performed at trial entry, and randomization was stratified according to age and antibiotic agent received. Analyses of safety, microbiome engraftment, and metabolites were also performed. RESULTS: spore germination. CONCLUSIONS: infection after treatment with standard-of-care antibiotics, oral administration of SER-109 was superior to placebo in reducing the risk of recurrent infection. The observed safety profile of SER-109 was similar to that of placebo. (Funded by Seres Therapeutics; ECOSPOR III ClinicalTrials.gov number, NCT03183128.).
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SER-109 is an oral microbiome therapeutic administered in capsule dosage form, eliminating the need for endoscopy procedures.
“Interestingly, SER-109 is an oral microbiome therapeutic administered in the capsule dosage form, eliminating the need for endoscopy procedures.729”
From Microbiota–gut–brain axis and its therapeutic applications in neurodegenerative diseases (2024) · cites this paper as [729]
FMT has achieved a significant milestone following FDA approval of RBX2660 (Rebyota) and SER-109 (Vowst) for prevention of recurrent Clostridioides difficile infection, highlighting therapeutic potential of FMT in human disease.
“Notably, FMT has achieved a significant milestone following the recent FDA approval of RBX2660 (Rebyota) and SER-109 (Vowst) for the prevention of recurrent Clostridioides difficile infection, highlighting the therapeutic potential of FMT in human disease.729–731”
From Microbiota–gut–brain axis and its therapeutic applications in neurodegenerative diseases (2024) · cites this paper as [729]
In a phase III trial, microbial consortia efficacy similar to fecal microbiota transplant was reported for Clostridioides difficile infection.
“including in a phase III trial in which efficacy similar to FMT was reported.10”
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- Authors
- Feuerstadt, P., Louie, T. J., Lashner, B., Wang, E. E. L., Diao, L., Bryant, J. A., Sims, M., Kraft, C. S., Cohen, S. H., Berenson, C. S., Korman, L. Y., Ford, C. B., Litcofsky, K. D., Lombardo, M.-J., Wortman, J. R., Wu, H., Auniņš, J. G., McChalicher, C. W. J., Winkler, J. A., McGovern, B. H., Trucksis, M., Henn, M. R., & von Moltke, L.
- Affiliations
- Cleveland Clinic (US)
- From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden — both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester — both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System — both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.).
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-01-20
- Volume
- 386
- Issue
- 3
- Pages
- 220-229
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4205375560
- Cited by
- 558
- References
- 37
- Citations by year
- 2026: 126 · 2025: 117 · 2024: 137 · 2023: 119 · 2022: 58
- FWCI
- 52.59
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Clostridium difficile and Clostridium perfringens research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Keywords
- SER-109, recurrent Clostridium difficile infection, fecal microbiota transplantation, spore germination, antibiotic-associated diarrhea, safety profile
- MeSH terms
- Bacillota, Aged, Anti-Bacterial Agents, Clostridium Infections, Double-Blind Method, Feces, Female, Humans, Male, Middle Aged, Recurrence, Spores, Bacterial, Clostridioides difficile, Gastrointestinal Tract, Secondary Prevention, Intention to Treat Analysis, Microbiota
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