Actively Recruiting
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
Led by Bausch Health Americas, Inc. · Updated on 2026-03-18
54
Participants Needed
5
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consent and assent are obtained before any study activities.
- Child is between 6 to 11 years old and weighs at least 15 kg (33 lbs) at screening.
- Females of childbearing potential have a negative pregnancy test and agree to use effective contraception during the study.
- Child has diarrhea suspected to be caused by bacteria with at least 3 unformed stools in the last 24 hours.
- Child has a fever between 100.4°F (38°C) and 102.2°F (39°C) or had such a fever since abdominal pain or diarrhea began.
- Illness duration is less than 96 hours at screening.
- Parent or guardian and child understand and agree to comply with study procedures and visits.
You will not qualify if you...
- History of chronic diarrhea.
- Unable to eat or drink.
- Fever above 102.2°F (39°C).
- Presence of visible blood in stool.
- Took more than 2 doses of anti-diarrheal treatments in the 24 hours before randomization.
- Used any oral antibiotics within 14 days before randomization.
- Unstable medical conditions including severe dehydration.
- Known significant liver or kidney disease.
- Serum sodium ≥150 mEq/L or serum potassium ≤3.0 mEq/L.
- Allergy or hypersensitivity to rifaximin, rifampin, rifamycin antibiotics, or rifaximin components.
- Pregnant or breastfeeding, or plans to become pregnant during the study.
- History of cancer or tuberculosis infection or treatment.
- Any illness or condition that could affect study data or compliance.
- Significant blood loss within 30 days prior to screening.
- Participation in another investigational drug or device study within 30 days.
- Immediate family member employed at study site in a role related to the study.
- Unwilling or unable to comply with study protocol.
- Abnormal serum glucose at screening.
- Taking medications that inhibit P-glycoprotein.
- Taking warfarin for a pre-existing condition.
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Trial Site Locations
Total: 5 locations
1
Direct Helpers
Hialeah, Florida, United States, 33012
Not Yet Recruiting
2
SouthCoast Research Center
Miami, Florida, United States, 33136
Actively Recruiting
3
Oceane7 Medical & Research Center, Inc
Miami, Florida, United States, 33144
Actively Recruiting
4
LinQ Research
Rosharon, Texas, United States, 77583
Actively Recruiting
5
Tekton Research
Richmond, Virginia, United States, 23233
Actively Recruiting
Research Team
A
Angela Moore
CONTACT
J
John Lahey VP, Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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