Phase 4
N=8
Effects of Intravenous (IV) Omadacycline on Gut Microbiome
Microbial Colonization
Bottom Line
View on ClinicalTrials.gov: NCT05515562 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Phylum Level Mean Proportional Relative Abundance — 0.167; 0.0271; 0.686; 0.0391 % gram positive (+) for phylum
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omadacycline Injection (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phylum Level Mean Proportional Relative Abundance |
0.198; 0.0459; 0.246; 0.152; 0.210; 0.147 | — |
| PRIMARY Phylum Level Mean Proportional Relative Abundance |
0.198; 0.0459; 0.246; 0.152; 0.210; 0.147 | — |
| PRIMARY Phylum Level Mean Proportional Relative Abundance |
0.198; 0.0459; 0.246; 0.152; 0.210; 0.147 | — |
| PRIMARY Phylum Level Mean Proportional Relative Abundance |
0.198; 0.0459; 0.246; 0.152; 0.210; 0.147 | — |
| PRIMARY Bacterial DNA Per Gram of Stool |
0.849; 9.97; .0148; 4.25; 103; 21.9 | — |
| PRIMARY Bacterial DNA Per Gram of Stool |
0.849; 9.97; .0148; 4.25; 103; 21.9 | — |
| PRIMARY Bacterial DNA Per Gram of Stool |
0.849; 9.97; .0148; 4.25; 103; 21.9 | — |
| PRIMARY Order Level Mean Proportional Relative Abundance |
0.0880; 0.0779; 0.0270; 0.0391; 0.0356; 0.416 | — |
| PRIMARY Order Level Mean Proportional Relative Abundance |
0.0880; 0.0779; 0.0270; 0.0391; 0.0356; 0.416 | — |
| PRIMARY Order Level Mean Proportional Relative Abundance |
0.0880; 0.0779; 0.0270; 0.0391; 0.0356; 0.416 | — |
| PRIMARY Order Level Mean Proportional Relative Abundance |
0.0880; 0.0779; 0.0270; 0.0391; 0.0356; 0.416 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05515562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.