Rifaximin + ORT for Diarrhea

Recruiting at 4 trial locations

Overseen By Angela Moore

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch Health Americas, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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 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

Are You a Good Fit for This Trial?

Inclusion Criteria

I have had diarrhea and a mild fever for less than 4 days.

I understand the study and am willing to follow all procedures and visits.

Consent and assent are appropriately obtained prior to any study related activities, including discontinuation of any prohibited medications (subjects must sign an assent for the study and a parent or a legal guardian must sign the informed consent).

Exclusion Criteria

Subject has a serum glucose level at screening that deviates from the reference range established by the central laboratory.

I have a history of chronic diarrhea.

Subject is unable to eat or drink.

What Are the Treatments Tested in This Trial?

Interventions

• Rifaximin

How Is the Trial Designed?

Group I: Rifaximin 200 mg + ORT Experimental Treatment 2 Interventions

rifaximin 200 mg tablets orally three times daily for 3 days plus oral rehydration therapy (ORT) administered per investigator standard of care

Group II: ORT Alone Active Control 1 Intervention

ORT administered per investigator standard of care without rifaximin.

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials

265

Recruited

82,000+

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University