Effects of Intravenous (IV) Omadacycline on Gut Microbiome
- Registration Number
- NCT05515562
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intravenous (IV) Omadacycline Omadacycline Injection All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline
- Primary Outcome Measures
Name Time Method Phylum Level Mean Proportional Relative Abundance Day 10 In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.
Bacterial DNA Per Gram of Stool End of Therapy up to Day 10 nanograms (ng) per gram of stool for bacterial DNA
Order Level Mean Proportional Relative Abundance Day 30 Order Level Mean Proportional Relative Abundance - Relative abundance % for order
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States