Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea (NCT07285785) | Clinical Trial Compass
RecruitingPhase 4
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
United States54 participantsStarted 2026-02-11
Plain-language 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
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Parent/legally authorized representative and participant, as applicable, have provided written informed consent/assent, are able to understand, and agree to comply with, all study procedures and requirements.
. Participant is between 6 to 11 years of age (inclusive)
. Participant weighs at least 15 kg (33 lbs) at Screening
. Participant is able to swallow pills
. Participant has diarrhea of suspected bacterial etiology defined by:
. At least 3 unformed stools in the last 24 hours prior to Screening
. Illness for less than 96 hours at Screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak Plasma Concentration (Cmax) of Rifaximin
Timeframe: Days 1 and 3
2
Time to Maximum Plasma Concentration (Tmax) of Rifaximin
Timeframe: Days 1 and 3
3
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) for Rifaximin
Timeframe: Days 1 and 3
4
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-τ) for Rifaximin
. Clinical presentation consistent with acute infectious diarrhea of suspected bacterial etiology
Exclusion criteria
. Participant has a history of chronic diarrhea (defined as loose or watery stools persisting for at last 4 consecutive weeks) within 12 months prior to onset of current acute illness.
. Participant is unable to eat or drink.
. Participant has clinical features suggestive of invasive or severe bacterial diarrhea requiring alternative therapy (e.g., frank blood in stool, mucoid diarrhea with systemic symptoms such as high fever, severe abdominal cramping or tenderness, or signs of sepsis).
. Participant has taken \>2 doses of anti-diarrheal therapies in the 24 hours prior to randomization.
. Participant has taken any oral antimicrobial drug within 14 days of randomization.
. Participant has a clinically significant or unstable medical condition, in the opinion of the Investigator, (including, but not limited to, evidence of severe dehydration noted by tachycardia, abnormal blood pressure, or decreased skin turgor) at the Screening visit.
. Participant has a known hypersensitivity or allergy to Xifaxan®, rifampin, rifamycin-derived antibiotics, or any of the components of the rifaximin (Xifaxan®) formulations used in this study.
. Participant is pregnant or lactating or plans to become pregnant during the study.