NCT05515562

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Effects of IV Omadacycline on Gut Microbiome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Microbial Colonization

Interventions

Type	Name	Description
DRUG	Omadacycline Injection	All participants will receive Intravenous (IV) omadacycline

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-07-11
• Completion: 2023-07-11
• First posted: 2022-08-25
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study