A Phase 4 interventional study of Rifaximin 200 mg Tablet and Oral Rehydration Therapy (ORT) in Diarrhea, Gastroenteritis and Bacterial Infection, sponsored by Bausch Health Americas, Inc.. Recruiting at 10 sites in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Bausch Health Americas, Inc. (part of Bausch Health Companies Inc.) · Phase 4, Interventional, and Treatment
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
This is a randomized, open-label study to assess the pharmacokinetics of Xifaxan® 200 mg in pediatric participants 6 to 11 years of age with acute diarrhea of suspected bacterial etiology, and safety and efficacy Xifaxan® 200 mg plus ORT compared to ORT alone.
Participants will receive Xifaxan® 200mg (1 tablet) TID plus oral rehydration therapy (ORT) or ORT alone as per the Investigator's Standard of Care (SOC) for administering ORS for three days.
Participants will complete 3 or 4 study visits during the study; Screening (Day -2 to Day 1), Day 1, Day 3 (End of Treatment), and Day 5 (Last Clinic Visit), and 2 safety follow-up phone calls; Once during Day 6 to 8, and on Day 30 (End of Study). Participants may complete both Screening and Day 1 on the same day. At the Screening visit, participants will provide a stool sample for PCR testing to identify the bacterial pathogen isolated. During the 5-day study period, the participant or their caregiver will complete a diary to record the dose, the time of dosing, time and consistency of stools, and incidence of symptoms as defined above. In addition, the participant or the caregiver will record any AEs in the eDiary from Day 4 to Day 30 with Day 1 to Day 3 assessed during study visits.
Participants in the Xifaxan® 200 mg plus ORT arm will undergo two 6 to 8-hour pharmacokinetic sampling periods, the first following the first dose on Day 1 and the second following the first dose on Day 3. During these sampling periods, 3 blood samples (approximately 4 mL each) will be collected for analysis of rifaximin and 25- desacetyl rifaximin plasma concentrations at the following times: pre-dose, 1 hour (+/- 10 minutes) and no less than 6 but no more than 8 hours following the first dose of the day.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 54 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Bausch Health Americas, Inc. is the lead sponsor of 213 studies on the registry; 7 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
First submitted after Bausch Health Americas, Inc. became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A participant will be eligible for inclusion in this study if all of the following criteria are met:
Participant has diarrhea of suspected bacterial etiology defined by:
Applicable to:
All Post-Menarche Female Particpants:
All Males Participants:
4.2 Exclusion Criteria
A participant will not be eligible for inclusion in this study if any of the following criteria are met:
The following therapies are prohibited from Screening through Day 5:
Anti-diarrheal medications, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
rifaximin 200 mg tablets orally three times daily for 3 days plus oral rehydration therapy (ORT) administered per investigator standard of care
Drug: Rifaximin 200 mg Tablet · Other: Oral Rehydration Therapy (ORT)
ORT administered per investigator standard of care without rifaximin.
Other: Oral Rehydration Therapy (ORT)
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 6 to 8 hours post-dose.
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.
Peak Plasma Concentration (Cmax) of Rifaximin
Cmax levels following rifaximin 200 mg + ORT
Time frame: Days 1 and 3
Time to Maximum Plasma Concentration (Tmax) of Rifaximin
Tmax for rifaximin following rifaximin 200 mg + ORT
Time frame: Days 1 and 3
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) for Rifaximin
Area under the concentration-time curve to last measurable concentration
Time frame: Days 1 and 3
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-τ) for Rifaximin
Area under the concentration-time curve over the dosing interval
Time frame: Days 1 and 3
Proportion of participants with Clinical Cure
Proportion of participants achieving clinical cure, defined as either: 1. No unformed stools within a 48-hour period with no fever (with or without other clinical symptoms such as abdominal cramps or pain, excess gas/flatulence, nausea, vomiting, urgency, tenesmus); or 2. No watery stools and no more than two soft stools within a 24-hour period with no fever and no other clinical symptoms except for mild excess gas/flatulence.
Time frame: Up to Day 5 (End of Treatment)
Time to Last Unformed Stool (TLUS)
Time in hours from the first dose of study treatment to the last unformed stool, after which clinical cure is declared, based on subject/caregiver diary entries.
Time frame: Up to Day 5 (End of Treatment)
Incidence of Treatment-Emergent Adverse Events (AEs)
Number and percentage of participants with AEs and SAEs
Time frame: Day 1-30
Change From Baseline in Clinical Laboratory Parameters
Changes in hematology, chemistry, and urinalysis values
Time frame: Day 1-30
Change From Baseline in Vital Signs
Change in temperature, blood pressure, and pulse
Time frame: Day 1-30
Detection of Bacterial Pathogens in stool samples
Identification of bacterial pathogen(s) isolated from stool samples of enrolled participants.
Time frame: Screening (Day -2 to Day 1)
Plan to share: No — The sponsor does not intend to share individual participant-level data from this study. Summary results will be posted in accordance with applicable regulations.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Apr 2027, 14 months after the start.
Of 37 phase 4 interventional studies under Diarrhea, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Rifaximin
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