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NCT06030219 · ClinicalTrials.gov registry record · Phase 1
Microbiome Effect of Omadacycline on Healthy Volunteers
A Phase 1 study, sponsored by University of Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT06030219: Completed Phase 1 study, sponsored by University of Houston.
NCT06030219 is a Phase 1 study that has completed, run by University of Houston. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06030219, a Phase 1 study, has completed, sponsored by University of Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The goal of this study is to assess microbiome changes associated with omadacycline vs. comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days 1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin 125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool and used for qPCR biomass and microbial metagenomic experiments. Results from the study will provide definitive data on the microbiome effects of omadacycline versus comparator antibiotics.
Primary Outcome
Metagenomic changes (16S rRNA) and qPCR for individual bacterial species
Interventions
- DRUG Moxifloxacin
- DRUG Omadacycline
- DRUG Vancomycin Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-10-12 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 1 |
What the finished NCT06030219 record still lists
NCT06030219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Moxifloxacin is the first listed.
NCT06030219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06030219 about?
NCT06030219 is a clinical study titled "Microbiome Effect of Omadacycline on Healthy Volunteers". The goal of this study is to assess microbiome changes associated with omadacycline vs. comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days 1 and 2 followed by 300 mg PO once...
What is the current status of trial NCT06030219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-10-12. Estimated completion is 2023-09-01.
What interventions are being tested in trial NCT06030219?
The interventions under investigation include: Moxifloxacin (DRUG), Omadacycline (DRUG), Vancomycin Pill (DRUG).
Who is sponsoring clinical trial NCT06030219?
This trial is sponsored by University of Houston, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06030219's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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