Study Focus
- Ages 6 to 11 years old
- Acute diarrhea symptoms
- 5-day study duration
Pediatric Clinical Research
Advancing care for children's digestive health.
A clinical research study evaluating a potential treatment for acute diarrhea in children ages 6 to 11. Discover if your child qualifies to participate and help us find faster relief.
Prioritizing safety and well-being in pediatric research.
Study Overview
Understanding the Research
We are evaluating a potential treatment approach for children ages 6 to 11 experiencing acute diarrhea suspected to be caused by a bacterial infection.
The Purpose
This clinical research study focuses on understanding how a study medication (rifaximin 200 mg) is processed in the body when combined with standard oral rehydration therapy (ORT), compared to using ORT alone. Acute diarrhea can be disruptive, and we aim to find effective ways to manage it in pediatric patients.
How It Works
Participants are randomly assigned to receive either the study medication alongside ORT, or ORT alone. Our medical team will carefully monitor safety, how the body absorbs the medication, and whether this combination helps resolve symptoms more effectively than current standard care.
What to Expect
- Take the study medication combined with ORT for 3 days, or receive ORT alone.
- Attend up to 4 brief clinic visits over a 5-day period for monitoring.
- Complete 4 follow-up phone calls with our dedicated care team.
- Provide necessary health samples and keep a simple daily symptom diary.
Who can join this study?
We are seeking children experiencing acute diarrhea to help us evaluate a potential treatment. Please review the guidelines below to see if this study might be a fit for your child.
Your child may qualify if:
- They are between 6 and 11 years old and weigh at least 33 lbs.
- They have had at least 3 loose or watery stools in the past 24 hours.
- They have or recently had a mild to moderate fever (between 100.4°F and 102.2°F).
- The diarrhea symptoms started less than 4 days ago.
This study may not be a fit if:
- Your child has severe dehydration requiring intravenous (IV) fluids.
- Your child has taken other antibiotics recently for this illness.
- Your child has a known chronic gastrointestinal condition.
Not sure if your child qualifies?
Take our quick eligibility quizStudy Care & Benefits
Participating in this clinical research study provides your child with dedicated medical attention while contributing to the advancement of pediatric care.
Study Medication Provided
Participants will receive the investigational medication and/or Oral Rehydration Therapy at no cost during the course of the trial.
Medical Monitoring
Comprehensive health assessments, including vital signs and laboratory monitoring by our specialized pediatric research team.
Expert Care Access
Direct access to study doctors and healthcare professionals through clinic visits and regular follow-up phone calls.
Advancing Science
Play a vital role in pediatric medical research that may help improve treatments for future children with acute diarrhea.
Study Information
Common Questions
Everything you need to know about your child's participation in the acute diarrhea study.
What is a clinical trial and is it safe?
A clinical trial is a carefully monitored research study that helps us understand how well a medication works and if it is safe. In this study, we are evaluating a medication called rifaximin for children ages 6 to 11 with acute diarrhea. Your child's safety is our highest priority, and their health will be closely monitored by medical professionals throughout the entire process.
How long will my child be in the study?
The study moves quickly to focus on your child's recovery. Their active participation will last approximately 5 days, which includes up to 4 brief clinic visits. Afterward, our study team will conduct 4 follow-up phone calls to check on their continued well-being.
What are the possible risks and side effects?
As with any medication, there are potential side effects. The study doctor will discuss all possible risks with you in detail before you make any decisions. Your child will be continuously monitored for any changes in vital signs, and you will keep a daily diary to track their symptoms and recovery.
Will our family's information be kept confidential?
Absolutely. Your family's privacy is strictly protected under US federal law (HIPAA). All medical records, stool and blood samples, and study data are kept completely confidential, anonymized, and stored in highly secure systems.
Can we leave the study if we change our minds?
Yes, participation is entirely voluntary. You or your child can choose to leave the study at any time, for any reason. Deciding to leave will not result in any penalty or affect the standard medical care your child receives.
Will my child receive the actual medication or a placebo?
In this study, there is no placebo. Participants are randomly assigned to receive either the study medication (rifaximin) plus standard oral rehydration therapy, or standard oral rehydration therapy alone. Both groups receive active, supportive care to help resolve their symptoms.
What happens after the study ends?
After the final clinic visit and follow-up calls, your child will return to their regular pediatrician for any ongoing care. The study team will provide you with all necessary health information from the trial to share with your primary doctor.