Gammaproteobacteria

ACG 2023 Presentations for REBYOTA® (fecal microbiota, live – jslm) Explore Association Between Gut Microbiome Composition and Health-Related Quality of Life and Evaluate Efficacy and Safety in Older Patients With Comorbidities

Retrieved on: 
Monday, October 23, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Clostridioides difficile infection, Yale School of Medicine, PUNCH, GI, Patient, American College, Food, Gammaproteobacteria, ACG, MD, Clostridioides difficile, Atrial fibrillation, Coronary artery disease, Safety, Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Bacteroidales, Microbiota, Multimedia, Life, Chronic kidney disease, Ferring Pharmaceuticals, AGAF, Recurrence, OLS, Bacteria, Kidney disease, Kidney, Overalls, Irritable bowel syndrome, FACG, Inflammatory bowel disease, Gastroesophageal reflux disease, Pharmaceutical industry, Bacilli

Patients were categorized as improved if Cdiff32 scores improved 10 points or more from baseline to week 8.

Key Points: 
  • Patients were categorized as improved if Cdiff32 scores improved 10 points or more from baseline to week 8.
  • The average microbiome profiles were then compared between baseline and week 8 within the improved and unchanged groups, respectively.
  • The analysis found that the quartile with the highest Cdiff32 score showed a significantly different microbiome composition from most other groups with lower scores.
  • “Seeing efficacy and safety consistent with previous clinical trials of REBYOTA among these higher-risk patients is encouraging.”

More Real-World Data and New Analyses of Data for REBYOTA® (fecal microbiota, live – jslm) Presented at IDWeek 2023

Retrieved on: 
Wednesday, October 11, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Ferring Pharmaceuticals, Multimedia, Food, Life, Bacteroidales, Bacteria, CKD, Insurance, Safety, Gammaproteobacteria, MHI, Recurrence, Kidney disease, Chronic kidney disease, Clostridioides difficile infection, Infection, Electronic health record, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mitt, Observation, PUNCH, Patient, Urinary tract infection, Clostridioides difficile, Pharmaceutical industry, Bacilli

Electronic health records, administration records and internal databases were reviewed for patient demographics, setting of care, time from order to treatment, logistics from order to administration and payor details.

Key Points: 
  • Electronic health records, administration records and internal databases were reviewed for patient demographics, setting of care, time from order to treatment, logistics from order to administration and payor details.
  • Early experience with REBYOTA showed an administration time of six minutes followed by 15 minutes of observation.
  • No one was denied insurance coverage for REBYOTA or the instillation procedure.
  • Within a modified intent-to-treat (mITT) population (n=402), 98 had renal comorbidity, including chronic kidney disease (CKD) (n=29) and end-stage renal failure (n=5).