Richmond, VANCT07285785Now EnrollingIRB Ready

Diarrhea Clinical Trial in Richmond, VA

Access cutting-edge diarrhea treatment through this clinical trial at a research site in Richmond. Study-provided care at no cost to qualified participants.

Sponsored by Bausch Health Americas, Inc.

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Expert Care in Richmond

Access diarrhea specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related diarrhea treatment provided free

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Check if you qualify for this diarrhea clinical trial in Richmond, VA

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Why Participate?

  • No-Cost Study Care

  • Local to Richmond

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Richmond site if eligible
  4. 4Begin participation

About This Diarrhea Study in Richmond

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

Sponsor: Bausch Health Americas, Inc.

Who Can Participate

Inclusion Criteria

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).
Subject is between 6 to 11 (and 11 months) years of age, inclusive, and weighs at least 15 kg (33 lbs) at Screening.
Females of childbearing (reproductive) potential must have a negative urine and serum pregnancy test at Screening and agree to use a highly effective method of contraception throughout their participation in the study. Acceptable methods of contraception are those alone or in combination, that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly and include hormonal methods (oral, injected or implanted), intrauterine device or intrauterine system or double barrier methods (simultaneous use of a physical barrier method by the subject and male partner, including a male condom and an occlusive cap \[diaphragm or cervical/vault cap\] with spermicidal). Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the Investigator. NOTE: Female subjects are considered of child-bearing potential if they are (a) physiologically capable of becoming pregnant, defined as a female who has experienced menarche and (b) they will be, or could possibly be, engaging in sexual activity during the course of the study.
Subject has diarrhea of suspected bacterial etiology defined by:
At least 3 unformed stools in the last 24 hours prior to Screening.
A fever ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) or has had a fever of ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) at any time since the development of abdominal pain or diarrhea.
Illness for less than 96 hours at Screening.
Parent or legal guardian and subject, when applicable based on aged, are capable of understanding the requirements of the study and willing to comply with all study procedures and visits.

Exclusion Criteria

Subject has a history of chronic diarrhea.
Subject is unable to eat or drink.
Subject has at least one of the following signs or symptoms:
Presence of fever \>39°C (\>102.2°F).
Presence of frank blood in stool.
Subject has taken \>2 doses of anti-diarrheal therapies in the 24 hours prior to randomization.
Subject has taken any oral antimicrobial drug within 14 days of randomization.
Subject has an unstable medical condition, in the opinion of the Investigator, (including, but not limited to, evidence of severe dehydration noted by tachycardia, abnormal blood pressure, or decreased skin turgor) at the Screening visit.
Subject has known, clinically significant hepatic disease manifested by twice the age and sex-adjusted upper limit of normal (2 × ULN) for any of the following liver function tests: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, or total bilirubin (except in isolated elevation of unconjugated bilirubin).
Subject has known, clinically significant renal disease (eg, 1.5 × ULN of serum creatinine or 2 × ULN of blood urea nitrogen levels).
Subject has serum sodium of ≥150 mEq/L and serum potassium ≤3.0 mEq/L.
Subject has a known hypersensitivity or allergy to Xifaxan®, rifampin, rifamycin-derived antibiotics, or any of the components of the rifaximin (Xifaxan®) formulations used in this study.
Subject is pregnant or lactating or plans to become pregnant during the study.
Subject has had a previous history of malignancy.
Subject has a history of tuberculosis infection and/or has received treatment for tuberculosis infection.
Subject has any concurrent illness, disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the Investigator.
Subject has had significant blood loss within the 30 days prior to the Screening visit which prevents the collection of the blood volume required for this study.
Subject has participated in an investigational drug or device study within the 30 days prior to randomization.
Subject's parent or legal guardian, or an immediate family member is an employee of the site that is directly involved in the management, administration, or support of this study.
Subject and/or legal guardian is unwilling or unable to comply with the study protocol for any other reason.
Subject has a serum glucose level at screening that deviates from the reference range established by the central laboratory.
Subject is taking a concomitant medication that is a P-glycoprotein (P-gp) inhibitor.
Subject is taking warfarin for a pre-existing condition.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Richmond?

Yes, this clinical trial (NCT07285785) has an active research site in Richmond, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diarrhea Treatment Options in Richmond, VA

If you're searching for diarrhea treatment options in Richmond, VA, this clinical trial (NCT07285785) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Richmond research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diarrhea specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diarrhea clinical trials near you to find additional studies recruiting in your area.

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