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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 is a Phase 1 study that has completed, run by University of Houston. The registered enrollment target is 32 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06030219
The ClinicalTrials.gov registry entry for NCT06030219 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Houston, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Moxifloxacin is the first listed.
NCT06030219 reports 0 study locations.
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.
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