Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
Public ClinicalTrials.gov record NCT07285785. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-Label Study to Assess Pharmacokinetics of Xifaxan® 200 mg in Pediatric Subjects 6 to 11 Years of Age With Acute Diarrhea of Suspected Bacterial Etiology, and the Safety and Efficacy of Xifaxan® 200 mg Plus Oral Rehydration Therapy (ORT) Compared to ORT Alone
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07285785
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 10, 2026
- Primary completion
- Apr 19, 2027
- Completion
- Jul 30, 2027
- Last update posted
- Aug 12, 2026
2026 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance Research Institute | Lynwood | California | 90262 | Recruiting |
| Direct Helpers | Hialeah | Florida | 33012 | Recruiting |
| SouthCoast Research Center | Miami | Florida | 33136 | Recruiting |
| Oceane7 Medical & Research Center, Inc | Miami | Florida | 33144 | Recruiting |
| Rophe Adult & Pediatric Medicine | Union City | Georgia | 30291 | Recruiting |
| Innovative Clinical Research Center | Island Lake | Illinois | 60042 | Recruiting |
| Cyn3rgy Research Corporation | Gresham | Oregon | 97030 | Recruiting |
| Little Stars Pediatrics / Tattva Trials | Prosper | Texas | 75078 | Recruiting |
| LinQ Research | Rosharon | Texas | 77583 | Recruiting |
| Tekton Research | Richmond | Virginia | 23233 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07285785, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07285785 live on ClinicalTrials.gov.