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Rifaximin for Acute Diarrhea in Children

This study is looking at how the medication rifaximin 200 mg works in children aged 6 to 11 years old who have acute diarrhea, possibly caused by bacteria. Researchers want to understand how the body processes rifaximin (pharmacokinetics) and if it's safe and effective when given with oral rehydration therapy (ORT). You would either receive rifaximin plus ORT or ORT alone. The main goals are to see how rifaximin moves through the body, if it's safe for children, and if adding rifaximin helps diarrhea resolve faster than ORT alone. The study is currently unclear on its recruitment status and plans to enroll 54 participants.

Study design
This is a randomized, open-label study, meaning participants are randomly assigned to a treatment group and everyone knows which treatment they are receiving. It will include 54 participants.
What's involved
Participants will take rifaximin 200 mg three times daily for 3 days or receive oral rehydration therapy. Blood samples will be collected on Day 1 and Day 3, and a daily diary will be kept to record symptoms.
Compensation
Not stated in the trial record.
Follow-up
Blood samples are collected on Day 1 and Day 3, and daily diaries are kept during treatment. The duration of follow-up after treatment is not specified.

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NCT07285785

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

Recruiting
PHASE4Ages 6–12InterventionalTreatment
Bausch Health Americas, Inc.
~54 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Rifaximin 200 mg TabletOral Rehydration Therapy (ORT)

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak Plasma Concentration (Cmax) of Rifaximin
Measured over Days 1 and 3
+4 more outcomes measured

Conditions

Diarrhea
Gastroenteritis
Bacterial Infection
Acute Diarrhea

Explore related trials

Acute diarrheaGastroenteritis

Where it's being run

10 sites across 7 states
Florida3
Texas2
California1
Georgia1
Illinois1
Oregon1
Virginia1

Who to contact

Angela Moore
[email protected]
843-877-2756
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Eligibility criteria

Inclusion

Highly effective hormonal contraception methods such as oral, implantable, injectable, vaginal ring, or transdermal contraception for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before study drug administration.
Total abstinence from sexual intercourse since the last menses before screening and agrees to total abstinence from screening until at least 30 days after last study drug administration.
Intrauterine device.
Condoms with spermicide.
Total abstinence from sexual intercourse from screening visit until at least 30 days after last study drug administration.
Anti-diarrheal medications, including:
Anti-motility agents (eg, loperamide, diphenoxylate, codeine, and paregoric).
Absorbent agents (eg, cholestryramine).
Anti-secretory agents (eg, bismuth subsalicylate, octreotide, and vapreotide).
Probiotics
Any antimicrobial agents with an expected activity against enteric bacterial pathogens
A P-glycoprotein (P-gp) inhibitor
Warfarin

What this trial measures

  • Peak Plasma Concentration (Cmax) of RifaximinDays 1 and 3

    Cmax levels following rifaximin 200 mg + ORT

  • Time to Maximum Plasma Concentration (Tmax) of RifaximinDays 1 and 3

    Tmax for rifaximin following rifaximin 200 mg + ORT

  • Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) for RifaximinDays 1 and 3

    Area under the concentration-time curve to last measurable concentration

  • Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-τ) for RifaximinDays 1 and 3

    Area under the concentration-time curve over the dosing interval

  • Proportion of participants with Clinical CureUp to Day 5 (End of Treatment)

    Proportion of participants achieving clinical cure, defined as either: 1. No unformed stools within a 48-hour period with no fever (with or without other clinical symptoms such as abdominal cramps or pain, excess gas/flatulence, nausea, vomiting, urgency, tenesmus); or 2. No watery stools and no more than two soft stools within a 24-hour period with no fever and no other clinical symptoms except for mild excess gas/flatulence.