Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
Start Date
2/11/2026
Completion Date
7/31/2027
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
Detailed Description
This is a randomized, open-label study to assess the pharmacokinetics of Xifaxan® 200 mg in pediatric participants 6 to 11 years of age with acute diarrhea of suspected bacterial etiology, and safety and efficacy Xifaxan® 200 mg plus ORT compared to ORT alone. Participants will receive Xifaxan® 200mg (1 tablet) TID plus oral rehydration therapy (ORT) or ORT alone as per the Investigator's Standard of Care (SOC) for administering ORS for three days. Participants will complete 3 or 4 study visits during the study; Screening (Day -2 to Day 1), Day 1, Day 3 (End of Treatment), and Day 5 (Last Clinic Visit), and 2 safety follow-up phone calls; Once during Day 6 to 8, and on Day 30 (End of Study). Participants may complete both Screening and Day 1 on the same day. At the Screening visit, participants will provide a stool sample for PCR testing to identify the bacterial pathogen isolated. During the 5-day study period, the participant or their caregiver will complete a diary to record the dose, the time of dosing, time and consistency of stools, and incidence of symptoms as defined above. In addition, the participant or the caregiver will record any AEs in the eDiary from Day 4 to Day 30 with Day 1 to Day 3 assessed during study visits. Participants in the Xifaxan® 200 mg plus ORT arm will undergo two 6 to 8-hour pharmacokinetic sampling periods, the first following the first dose on Day 1 and the second following the first dose on Day 3. During these sampling periods, 3 blood samples (approximately 4 mL each) will be collected for analysis of rifaximin and 25- desacetyl rifaximin plasma concentrations at the following times: pre-dose, 1 hour (+/- 10 minutes) and no less than 6 but no more than 8 hours following the first dose of the day.
Eligibility Criteria
Age Range: 6 years to 12 years
Interventions
Rifaximin 200 mg Tablet
Oral Rehydration Therapy (ORT)
Conditions
Locations
Alliance Research Institute
Lynwood, California 90262
United States
Direct Helpers
Hialeah, Florida 33012
United States
SouthCoast Research Center
Miami, Florida 33136
United States
Oceane7 Medical & Research Center, Inc
Miami, Florida 33144
United States
Rophe Adult & Pediatric Medicine
Union City, Georgia 30291
United States
Innovative Clinical Research Center
Island Lake, Illinois 60042
United States
Cyn3rgy Research Corporation
Gresham, Oregon 97030
United States
Little Stars Pediatrics / Tattva Trials
Prosper, Texas 75078
United States
LinQ Research
Rosharon, Texas 77583
United States
Tekton Research
Richmond, Virginia 23233
United States