Effects of Intravenous (IV) Omadacycline on Gut Microbiome

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborators: High Point University; Paratek Pharmaceuticals Inc; University of Houston

Criteria

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