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New treatment option for Acute Gastroenteritis
Official title Fortified Oral Rehydration Therapy for Pediatric Diarrhea
ClinicalTrials.gov ID: NCT06137014
What this study is testing
What is Fortified Oral Rehydration Therapy?
Fortified Oral Rehydration Therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute gastroenteritis.
Also referred to as FORT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to compare amino acid-fortified oral rehydration therapy (ORT) to the standard of care ORT in pediatric patients with acute gastroenteritis (AGE). The main questions it aims to answer are: can amino acid-fortified ORT reduce the duration and severity of AGE compared to standard of care ORT?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 5
You may be able to join if
- Between the ages of 6 months and 5 years.
- Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.
- Diarrhea presumed infectious
You likely can't join if
- Severe gastroenteritis with moderate to severe dehydration
- Requiring inpatient care
- Requiring antibiotics
- Requiring IV rehydration
- History of chronic diarrhea
- Presenting with diarrhea for greater than 2 days prior to admission
See the full eligibility criteria
- Between the ages of 6 months and 5 years.
- Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.
- Diarrhea presumed infectious
- Severe gastroenteritis with moderate to severe dehydration
- Requiring inpatient care
- Requiring antibiotics
- Requiring IV rehydration
- History of chronic diarrhea
- Presenting with diarrhea for greater than 2 days prior to admission
- Allergy to any of the ingredients in the study products
- Inborn metabolic disorder of amino acids
- Receives post-pyloric feedings
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 5 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.