Microbiome Effect of Omadacycline on Healthy Volunteers
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06030219
- Lead Sponsor
- University of Houston
- Brief Summary
The goal of this study is to assess microbiome changes associated with omadacycline vs. comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days 1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin 125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool and used for qPCR biomass and microbial metagenomic experiments. Results from the study will provide definitive data on the microbiome effects of omadacycline versus comparator antibiotics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin (oral) Vancomycin Pill Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days. Omadacycline Omadacycline Subjects will receive 3 tablets on day 1 and day 2 (450 mg) followed by 2 tablets (300 mg) for days 3 through 10. Moxifloxacin Moxifloxacin Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days.
- Primary Outcome Measures
Name Time Method Microbiome changes During dosing and 30 day follow up period Metagenomic changes (16S rRNA) and qPCR for individual bacterial species
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Houston
🇺🇸Houston, Texas, United States