Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea (NCT07285785)
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
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Alliance Research Institute — Lynwood, California
Age range: 6 Years to 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- Alliance Research Institute — Lynwood, California
- Direct Helpers — Hialeah, Florida
- SouthCoast Research Center — Miami, Florida
- Oceane7 Medical & Research Center, Inc — Miami, Florida
- Rophe Adult & Pediatric Medicine — Union City, Georgia
- Innovative Clinical Research Center — Island Lake, Illinois
- Cyn3rgy Research Corporation — Gresham, Oregon
- Little Stars Pediatrics / Tattva Trials — Prosper, Texas
- LinQ Research — Rosharon, Texas
- Tekton Research — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: (843) 877-2756
Email: angela.moore@bauschhealth.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diarrhea
- Wells and Enteric Disease Transmission — Philadelphia, Pennsylvania
- A Study of SER-155 to Treat Diarrhea in People on Immunotherapy — Basking Ridge, New Jersey
Explore by condition: All Diarrhea clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.