NCT07285785

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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 study is a randomized, open-label clinical trial designed to evaluate the pharmacokinetics, safety, and efficacy of rifaximin 200 mg in pediatric participants aged 6 to 11 years with acute diarrhea of suspected bacterial etiology. Acute diarrhea may be caused by bacterial infections such as E. coli, Shigella, Salmonella, or Campylobacter. Participants are randomly assigned to receive either rifaximin 200 mg plus oral rehydration therapy (ORT) or ORT alone. Participants in the rifaximin group take one tablet three times a day for 3 days, in addition to ORT according to the investigator's standard of care. Participants in the ORT-alone group receive ORT only. The primary objective is to assess how rifaximin is absorbed, distributed, and eliminated in children (pharmacokinetics). Secondary objectives include evaluating the safety and tolerability of rifaximin and assessing whether rifaximin plus ORT helps resolve diarrhea faster than ORT alone. Safety assessments include monitoring adverse events, vital signs, and laboratory tests (hematology, chemistry, and urinalysis). Participants or their caregivers keep a daily diary to record stool frequency and consistency, time to last unformed stool, and any related symptoms such as abdominal cramps, nausea, vomiting, or flatulence. Stool samples are collected to identify the bacterial pathogen(s) causing diarrhea. Pharmacokinetic assessments are conducted in participants receiving rifaximin plus ORT, with blood samples collected on Day 1 and Day 3: pre-dose, 1 hour post-dose, and 8 hours post-dose. Plasma samples are analyzed for rifaximin and 25-desacetyl rifaximin to determine pharmacokinetic parameters, including maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC). Participants attend up to four clinic visits over the 5-day study period and receive follow-up phone calls on Days 6, 7, 8, and 30 to monitor safety and collect diary information. Compliance with study drug and ORT administration is assessed throughout the study. This study is designed to provide information on rifaximin pharmacokinetics, its safety in children, and the potential benefit of rifaximin plus ORT in resolving acute diarrhea of suspected bacterial origin.

Conditions

• Diarrhea
• Gastroenteritis
• Bacterial Infection

Interventions

Type	Name	Description
DRUG	Rifaximin 200 mg Tablet	Participants receive rifaximin 200 mg tablets orally three times daily (TID) for 3 days in combination with oral rehydration therapy (ORT). Blood samples for pharmacokinetic analysis are collected on Day 1 and Day 3 at pre-dose, 1 hour post-dose, and 8 hours post-dose.
OTHER	Oral Rehydration Therapy (ORT)	Participants receive oral rehydration solution according to the investigator's standard of care. This is administered either alone (for the ORT-alone arm) or in combination with rifaximin (for the rifaximin + ORT arm). Participants or caregivers complete a daily diary documenting stool frequency, stool consistency, and related symptoms.

Timeline

• Start date: 2026-02-11
• Primary completion: 2027-04-20
• Completion: 2027-07-31
• First posted: 2025-12-16
• Last updated: 2026-03-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study