Fortified Oral Rehydration Therapy for Pediatric Diarrhea

🩺 Protocol Summary

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? * can amino acid-fortified ORT increase the secretion of antimicrobial peptides in the gastrointestinal tract compared to standard of care ORT? Participants will be assigned to the experimental treatment (amino acid-fortified ORT) or the standard of care ORT and their disease severity, duration, and stool antimicrobial peptide content.

Primary Research Facility: Robert Wood Johnson University Hospital (New Brunswick, New Jersey)

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Acute Gastroenteritis?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged between 6 Months and 5 Years?

🔍 Protocol Specified Age Range: 6 Months to 5 Years

Able to attend required clinic visits at Robert Wood Johnson University Hospital (New Brunswick, New Jersey)?

🔍 Logistical Requirement: Site at Robert Wood Johnson University Hospital

📍 Primary Site Map

Site: Robert Wood Johnson University Hospital — New Brunswick, New Jersey

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.