Overview

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