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

Part of paid clinical trials in Hialeah, Florida.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT07285785
Phase
PHASE4
Status
Recruiting
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Conditions

  • Bacterial Infection
  • Diarrhea
  • Gastroenteritis

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Rifaximin 200 mg Tablet — DRUG
    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.
  • Oral Rehydration Therapy (ORT) — OTHER
    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.

Study Details

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

Key Dates

Start date
Feb 11, 2026
Status verified
Mar 2026
Primary completion
Apr 20, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rifaximin 200 mg + ORT
    rifaximin 200 mg tablets orally three times daily for 3 days plus oral rehydration therapy (ORT) administered per investigator standard of care
  • Active Comparator: ORT Alone
    ORT administered per investigator standard of care without rifaximin.

Primary Outcome Measure

Peak Plasma Concentration (Cmax) of Rifaximin [ Time Frame: Days 1 and 3 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Direct HelpersHialeahFlorida33012
Primary Coordinator
[email protected]
305-828-3555
Manuel Sanchez (PRINCIPAL_INVESTIGATOR)
Oceane7 Medical & Research Center, IncMiamiFlorida33144
Primary Coordinator
[email protected]
305-261-2738
Edgar Gonzalez, MD (PRINCIPAL_INVESTIGATOR)
SouthCoast Research CenterMiamiFlorida33136
Primary Coordinator
[email protected]
786-332-2721
Adonis Maiquez (PRINCIPAL_INVESTIGATOR)
LinQ ResearchRosharonTexas77583
Primary Coordinator
[email protected]
281-916-4220
Frederick Ogwara (PRINCIPAL_INVESTIGATOR)
Tekton ResearchRichmondVirginia23233
Primary Coordinator
[email protected]
804-430-5700
David Gosselin (PRINCIPAL_INVESTIGATOR)

Find similar trials in Hialeah, FL

By research site
Direct Helpers· Hialeah, FLOceane7 Medical & Research Center, Inc· Miami, FLSouthCoast Research Center· Miami, FLLinQ Research· Rosharon, TXTekton Research· Richmond, VA

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