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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.
Fecal microbiota spores, live-brpk (VOWST™/VOS) for prevention of recurrent infection.
Future Microbiol
November 2024
C. difficile Clinic & Microbiome Restoration Program, Division of Gastroenterology & Hepatology, Mayo Clinic, Rochester, MN 55905, USA.
infection (CDI) is a health crisis comprising a majority of healthcare-associated infections and is now being seen in the community. Persistent dysbiosis despite treatment with standard-of-care antibiotics increases risk of recurrent infections. Fecal microbiota transplantation has been an effective way of addressing dysbiosis, but the studies have lacked standardization, which makes outcome and safety data difficult to interpret.
View Article and Find Full Text PDFEnd-to-end donor screening and manufacturing controls: complementary quality-based strategies to minimize patient risk for donor-derived microbiome therapeutics.
Gut Microbes
September 2024
Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA.
Advances in microbiome therapeutics have been motivated by a deeper understanding of the role that the gastrointestinal microbiome plays in human health and disease. The FDA approval of two stool-derived live biotherapeutic products (LBPs), REBYOTA® 150 mL enema (fecal microbiota, live-jslm; formerly RBX2660) and VOWST® oral capsules (fecal microbiota spores, live-brpk; formerly SER-109), for the prevention of recurrent CDI in adults following antibiotic treatment for recurrent CDI provides promise and insights for the development of LBPs for other diseases associated with microbiome dysfunction. Donor-derived products carry risk of disease transmission that must be mitigated through a robust donor screening program and downstream manufacturing controls.
View Article and Find Full Text PDFIntegrated 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.
Microbiota restoration therapies for recurrent infection reach an important new milestone.
Therap Adv Gastroenterol
May 2024
GST Micro LLC, North, VA, USA.
Article Synopsis
- Microbiota restoration therapy is a new treatment for a recurring infection called rCDI, using special products made from healthy gut bacteria.
- Two main products have been approved: RBX2660 (REBYOTA™) and SER-109 (VOWST™), both aimed at preventing rCDI and helping doctors understand their differences.
- Research shows these treatments are safe and effective, and they help restore a healthy balance of gut bacteria, which is important for fighting infections.
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