Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07285785 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 5 → 10 locations Eligibility criteria shortened, about 95 words · Study description shortened, about 23 wordsv3 Show 2 more changesShow less
    • Eligibility criteria shortened, about 95 words
    • Study description shortened, about 23 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date changed from estimate of Dec 20, 2025 to Feb 11, 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of Dec 20, 2025 to Feb 11, 2026
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07285785
Lead Sponsor Bausch Health Americas, Inc.
Conditions Diarrhea, Gastroenteritis, Bacterial Infection, Acute Diarrhea
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov