Phase 4
Completed N=8
Effects of Intravenous (IV) Omadacycline on Gut Microbiome
Microbial Colonization
Source: ClinicalTrials.gov NCT05515562 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Phylum Level Mean Proportional Relative Abundance — 0.167; 0.0271; 0.686; 0.0391 % gram positive (+) for phylum
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 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 | — |
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. Informational only — not medical advice.