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meRfi® Microbiome - The Digital Gut Microbiome Reference (incl. AI Chat)
Prebiotics, Probiotics, FMT / Manipulators of the Intestinal Microbiota

AuthorsReferences (Sources)

AuthorsReferences (Sources)

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SER-109 & Clostridioides difficile infection (CDI) (recurrent)

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Approval status

The US Food and Drug Administration (FDA) approved SER‑109 on April 26, 2023 as the first orally administered fecal microbiota–based product for preventing Clostridioides difficile infection (CDI) (recurrent) in adults aged ≥18 years after completing antibiotic treatment for CDI. The indication is specifically for prevention of CDI recurrence, based on the phase 3 ECOSPOR III trial showing significantly lower recurrence rates with SER‑109 versus placebo (1, 2, 3, 4, 5).

Randomized clinical trials (RCTs)

References (Sources)

Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst's FDA approval and implications
Jain et al. 2023 Gut Microbes 15(1): 2232137
Assessment of quality of life among patients with recurrent Clostridioides difﬁcile infection treated with investigational oral microbiome therapeutic SER-109: secondary analysis of a randomized clinical trial
Garey et al. 2023 JAMA Netw Open 6: e2253570
Microbiota-Based Therapeutics as New Standard-of-Care Treatment for Recurrent Clostridioides difficile Infection
Stallhofer et al. 2024 Visc Med 40(2): 82-91
Review
SER-109, an Investigational Microbiome Drug to Reduce Recurrence After Clostridioides difficile Infection: Lessons Learned From a Phase 2 Trial
McGovern et al. 2021 cid 2021: 72
SER-109: An Oral Investigational Microbiome Therapeutic for Patients with Recurrent Clostridioides difficileInfection (rCDI)
Khanna et al. 2022 Antibiotics (Basel) 11(9): 1234
Review
SER109, an oral microbiome therapy for recurrent Clostridioides difﬁcile infection
Feuerstadt et al. 2022 N Engl J Med 386: 220-229
Update on microbiota-derived therapies for recurrent Clostridioides difficile infections
Benech et al. 2024 Clinical Microbiology and Infection 30: 462-468
Review

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7/1/2026

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Links

https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides)