AI Article Synopsis
- CDI is a significant health issue linked to hundreds of thousands of cases in hospitals and a notable number of deaths, with a high chance of recurrence for patients, emphasizing the importance of microbiome restoration in treatment.
- A systematic review was conducted on the effectiveness of VOS (Vowst Oral Spores) in preventing recurrent CDI after standard antibiotic treatment, analyzing various clinical trials.
- Results show that VOS significantly reduces the recurrence of CDI and helps restore the microbiome quickly, also improving patients' quality of life compared to placebo treatments.
Article Abstract
Background: infection (CDI) has been linked to over 200,000 cases of illness in hospitalized patients and over 20,000 deaths annually. Up to 25% of patients with an initial CDI episode will experience recurrent CDI (rCDI), which most commonly occurs in the first 8 weeks following antibiotic therapy. In patients with first or multiple rCDI, infection, the microbiome is similarly disrupted, which highlights the challenges of using antibiotics alone while underscoring the need for microbiome restoration regardless of the number of recurrences. In this systematic review, we describe the role of the gastrointestinal microbiome in CDI, and systematically review fecal microbiota spores, live-brpk (VOWST™; VOS for Vowst Oral Spores) for prevention of recurrence in rCDI.
Methods: The PubMed database was searched using "recurrent infection" AND (SER-109 OR VOS) and limited to clinical trials. The search yielded 7 results: 3 articles describing 3 clinical trials (two Phase 3 trials (ECOSPOR III and ECOSPOR IV) and one Phase 2 trial (ECOSPOR)), 1 describing follow-up of ECOSPOR III, 1 describing a post hoc analysis of comorbidities in ECOSPOR III, and 2 describing health-related quality of life in ECOSPOR III.
Results: Compared with placebo, VOS following standard-of-care antibiotics for CDI significantly reduced risk of recurrence at 8 weeks (relative risk, 0.32 (95% CI: 0.18-0.58); < 0.001; number needed to treat: 4) with a tolerable safety profile; rCDI rates remained low through 24 weeks. The disrupted microbiome, secondary to/exacerbated by antibiotic treatment, was rapidly (i.e., Week 1) restored with VOS. Compared with placebo, VOS demonstrated greater improvements in health-related quality of life.
Conclusions: Clinical care of patients with rCDI now includes Food and Drug Administration-approved therapeutics to address microbiome restoration. Clinical trial evidence supports use of VOS following antibiotics and importance of microbiome restoration in rCDI.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11462573 | PMC |
| http://dx.doi.org/10.1177/20503121241274192 | DOI Listing |
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Article Synopsis
- CDI is a significant health issue linked to hundreds of thousands of cases in hospitals and a notable number of deaths, with a high chance of recurrence for patients, emphasizing the importance of microbiome restoration in treatment.
- A systematic review was conducted on the effectiveness of VOS (Vowst Oral Spores) in preventing recurrent CDI after standard antibiotic treatment, analyzing various clinical trials.
- Results show that VOS significantly reduces the recurrence of CDI and helps restore the microbiome quickly, also improving patients' quality of life compared to placebo treatments.
Correction to: Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.
Infect Dis Ther
October 2024
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.
Infect Dis Ther
October 2024
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
Introduction: Recurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to prevent rCDI following antibiotics for rCDI.
Objective, Design, And Patients: To evaluate safety and efficacy of VOS from two phase 3 trials, (randomized, placebo-controlled [ECOSPOR III: NCT03183128] and open-label, single arm [ECOSPOR IV: NCT03183141]) of 349 adults with rCDI and prevalent comorbidities.
SER-109 (VOWST): A Review in the Prevention of Recurrent Clostridioides difficile Infection.
Drugs
March 2024
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
SER-109 (VOWST; fecal microbiota spores, live-brpk) is a live biotherapeutic product indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following standard of care (SOC) antibacterial treatment for recurrent CDI. It is a purified bacterial spore suspension sourced from healthy donors. As the first oral faecal microbiota product approved for prevention of recurrent CDI, SER-109 is administered as four capsules once daily for three consecutive days.
View Article and Find Full Text PDFImpact of a Purified Microbiome Therapeutic on Abundance of Antimicrobial Resistance Genes in Patients With Recurrent Clostridioides difficile Infection.
Clin Infect Dis
April 2024
Seres Therapeutics, Cambridge, Massachusetts, USA.
Background: The gastrointestinal microbiota is an important line of defense against colonization with antimicrobial resistant (AR) bacteria. In this post hoc analysis of the phase 3 ECOSPOR III trial, we assessed impact of a microbiota-based oral therapeutic (fecal microbiota spores, live; VOWST Oral Spores [VOS], formerly SER-109]; Seres Therapeutics) compared with placebo, on AR gene (ARG) abundance in patients with recurrent Clostridioides difficile infection (rCDI).
Methods: Adults with rCDI were randomized to receive VOS or placebo orally for 3 days following standard-of-care antibiotics.
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