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NCT07285785 · ClinicalTrials.gov registry record · Phase 4
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
A Phase 4 study of Diarrhea and Bacterial Infection, sponsored by Bausch Health Americas.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
- 5
- Study locations
NCT07285785 is a Phase 4 study of Diarrhea and Bacterial Infection that is actively recruiting participants, run by Bausch Health Americas. The registered enrollment target is 54 participants, below the 155-participant average among 24 other Diarrhea trials with a reported enrollment target (65% lower). The trial reports 5 study locations across 3 states.
The verdict
NCT07285785, a Phase 4 study of Diarrhea and Bacterial Infection, is actively recruiting participants, sponsored by Bausch Health Americas.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (ORT) compared with ORT alone. The main questions it aims to answer are: How does rifaximin 200 mg move through and leave the body in children with acute diarrhea? Is rifaximin safe for children in this age group? Does rifaximin plus ORT help resolve diarrhea faster than ORT alone? Researchers will compare rifaximin plus ORT to ORT alone to see if adding rifaximin improves outcomes. Participants will: Take one rifaximin 200 mg tablet + ORT three times a day for 3 days or receive ORT alone Receive oral rehydration therapy according to the investigator's standard of care Attend up to 4 clinic visits over 5 days and receive 4 follow-up phone calls Provide blood samples on Day 1 and Day 3 for pharmacokinetic testing (rifaximin group only) Provide stool samples to identify bacterial pathogens Keep a diary of stool frequency and consistency to help determine when diarrhea resolves Be monitored for side effects, vital signs, and laboratory changes
Conditions Studied
Interventions
- DRUG Rifaximin 200 mg Tablet
- OTHER Oral Rehydration Therapy (ORT)
Study Locations (5)
Florida
- Direct Helpers - Hialeah
- SouthCoast Research Center - Miami
- Oceane7 Medical & Research Center, Inc - Miami
Texas
- LinQ Research - Rosharon
Virginia
- Tekton Research - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2026-02-11 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07285785
The ClinicalTrials.gov registry entry for NCT07285785 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 155-participant average among 24 other Diarrhea trials with a reported enrollment target (65% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Diarrhea appearing as the primary indexed condition, and to 2 interventions - of which Rifaximin 200 mg Tablet is the first listed.
NCT07285785 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Florida, Texas, Virginia.
Frequently Asked Questions
What is clinical trial NCT07285785 about?
NCT07285785 is a clinical study titled "Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea". The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (...
What is the current status of trial NCT07285785?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2026-02-11. Estimated completion is 2027-07-31.
What conditions does trial NCT07285785 study?
This clinical trial studies the following conditions: Diarrhea, Bacterial Infection, Gastroenteritis.
What interventions are being tested in trial NCT07285785?
The interventions under investigation include: Rifaximin 200 mg Tablet (DRUG), Oral Rehydration Therapy (ORT) (OTHER).
Who is sponsoring clinical trial NCT07285785?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07285785 being conducted?
This trial has 5 study locations across Florida, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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