Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
Recruiting
Phase 4
Interventional Study
Diarrhea
Gastroenteritis
Bacterial Infection
Acute Diarrhea
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 12
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 54 (estimated)
- Sponsor
- Bausch Health Americas, Inc. · Industry
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About This Trial
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 m…
Trial Locations
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Eligibility Criteria
4.1 Inclusion Criteria
A participant will be eligible for inclusion in this study if all of the following criteria are met:
1. Parent/legally authorized representative and participant, as applicable, have provided written informed consent/assent, are able to understand, and agree to comply with, a…