The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.
A Novel Microbiome Therapeutic Increases Gut Microbial Diversity and Prevents Recurrent Clostridium difficile Infection
Abstract
BACKGROUND: Patients with recurrent Clostridium difficile infection (CDI) have a ≥60% risk of relapse, as conventional therapies do not address the underlying gastrointestinal dysbiosis. This exploratory study evaluated the safety and efficacy of bacterial spores for preventing recurrent CDI. METHODS: Stool specimens from healthy donors were treated with ethanol to eliminate pathogens. The resulting spores were fractionated and encapsulated for oral delivery as SER-109. Following their response to standard-of-care antibiotics, patients in cohort 1 were treated with SER-109 on 2 consecutive days (geometric mean dose, 1.7 × 10(9) spores), and those in cohort 2 were treated on 1 day (geometric mean dose, 1.1 × 10(8) spores). The primary efficacy end point was absence of C. difficile-positive diarrhea during an 8-week follow-up period. Microbiome alterations were assessed. RESULTS: Thirty patients (median age, 66.5 years; 67% female) were enrolled, and 26 (86.7%) met the primary efficacy end point. Three patients with early, self-limiting C. difficile-positive diarrhea did not require antibiotics and tested negative for C. difficile at 8 weeks; thus, 96.7% (29 of 30) achieved clinical resolution. In parallel, gut microbiota rapidly diversified, with durable engraftment of spores and no outgrowth of non-spore-forming bacteria found after SER-109 treatment. Adverse events included mild diarrhea, abdominal pain, and nausea. CONCLUSIONS: SER-109 successfully prevented CDI and had a favorable safety profile, supporting a novel microbiome-based intervention as a potential therapy for recurrent CDI.
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Cites
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Cited by
European consensus conference on faecal microbiota transplantation in clinical practice
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Clostridium difficile infection
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SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection
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Metadata
- Authors
- Khanna, S., Pardi, D. S., Kelly, C. R., Kraft, C. S., Dhere, T., Henn, M. R., Lombardo, M.-J., Vulic, M., Ohsumi, T., Winkler, J., Pindar, C., McGovern, B. H., Pomerantz, R. J., Aunins, J. G., Cook, D. N., & Hohmann, E. L.
- Venue
- Journal of Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2016-02-08
- Volume
- 214
- Issue
- 2
- Pages
- 173-181
- ISSN
- 0022-1899 (ISSN-L)
- 1537-6613
- OpenAlex
- W2298483969
- Cited by
- 321
- References
- 16
- FWCI
- 39.49
- Type
- journal article
- Language
- en
- Open access
- closed
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- Khanna, S., Pardi, D. S., Kelly, C. R., Kraft, C. S., Dhere, T., Henn, M. R., Lombardo, M.-J., Vulic, M., Ohsumi, T., Winkler, J., Pindar, C., McGovern, B. H., Pomerantz, R. J., Aunins, J. G., Cook, D. N., & Hohmann, E. L. (2016). A Novel Microbiome Therapeutic Increases Gut Microbial Diversity and Prevents Recurrent Clostridium difficile Infection. Journal of Infectious Diseases. https://doi.org/10.1093/infdis/jiv766
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