Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Effects of IV Omadacycline on Gut Microbiome

Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteers.

The plan to enroll eight healthy volunteers between the ages of 18 and 40 years and without history of cardiovascular, gastrointestinal, hepatic, or renal disease to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline. Stool and saliva samples will be collected at pre-specified times and analyzed to characterize the impact of IV omadacycline on gut microbiome.

Inclusion Criteria:

• 18-40 years of age
• Willing and able to comply with all study procedures
• Considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease
• males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline

Exclusion Criteria:

• Consumed probiotics within 30 days before enrollment
• Consumed antibiotics within 90 days prior to enrollment
• Known hypersensitivity to omadacycline or tetracycline-class antibiotics
• pregnant or breastfeeding
• in the opinion of the investigator is experiencing signs or symptoms of acute illness that increase the risk of adverse effects from participating in the study
• previously participated in the study