Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Launched by PAUL A BRESLIN · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for young children with diarrhea caused by a stomach infection, known as acute gastroenteritis. Researchers want to see if a special type of oral rehydration therapy (ORT) that is fortified with amino acids can help children get better faster and reduce the severity of their symptoms compared to the standard ORT that is commonly used. They are also interested in whether this new treatment can help the body produce more natural substances that fight infections in the gut.

Children aged between 6 months and 5 years who have been experiencing mild to moderate diarrhea for less than two days may be eligible to participate in this study. Participants will be assigned to either the new amino acid-fortified ORT or the standard treatment. Throughout the trial, doctors will monitor how severe the diarrhea is, how long it lasts, and measure the levels of infection-fighting substances in their stool. It’s important to note that children with more severe cases requiring hospitalization or treatment like antibiotics will not be included in this study. The trial is currently recruiting participants, and it's a chance for families to contribute to important research that could improve treatments for diarrhea in young children.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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