MedTrace Logo

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

NCT06137014 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

  • Acute Gastroenteritis

Interventions

DRUG

Fortified Oral Rehydration Therapy

Oral rehydration solution with reduced glucose and added amino acids.

DIETARY_SUPPLEMENT

Standard of Care Oral Rehydration Therapy

Glucose-based oral rehydration therapy according to World Health Organization guidelines.

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • Paul A Breslin

    lead OTHER

Principal Investigators

  • Paul Breslin, PhD · Rutgers, The State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06137014 on ClinicalTrials.gov