Recruiting
Phase 1
Phase 2

Fortified Oral Rehydration Therapy

Sponsor:

Paul A Breslin

Code:

NCT06137014

Conditions

Acute Gastroenteritis

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

Interventions

Fortified Oral Rehydration Therapy

Standard of Care Oral Rehydration Therapy

Study Details

Brief 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

Study ID

NCT06137014

Start date

Jun 1, 2024

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Amino acid-fortified oral rehydration therapy

Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the World Health Organization (WHO) Treatment Plan A for ORT administration:

  • Child under 24 months: 50 to 100 ml ORT after each loose stool (approximately 500 ml daily)
  • Child from 2 to 10 years: 100 to 200 ml ORT after each loose stool (approximately 1000 ml daily)

placebo comparator: Standard of care oral rehydration therapy

Participants will consume the standard of care oral rehydration therapy according to the WHO Treatment Plan A for ORT administration:

  • Child under 24 months: 50 to 100 ml after each loose stool (approximately 500 ml daily)
  • Child from 2 to 10 years: 100 to 200 ml after each loose stool (approximately 1000 ml daily)

Interventions

Fortified Oral Rehydration Therapy

Oral rehydration solution with reduced glucose and added amino acids.

Standard of Care Oral Rehydration Therapy

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

Primary outcome measure

  • Daily Stool Frequency [ Time Frame: Up to 14 days ]
  • Daily Stool Mass [ Time Frame: Up to 14 days ]
  • Duration of Diarrhea [ Time Frame: Up to 14 days ]

Central Contacts and Locations

Central contacts

Paul Breslin, PhD

(848) 932-6085breslin@monell.org

Payton Harmon

978-944-8484payton.harmon@rutgers.edu

Locations

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Paul AS Breslin, PhD

848-932-6080pasb@sebs.rutgers.edu

Payton Harmon, BS

978-944-8484payton.harmon@rutgers.edu

More Information

Sponsor

Paul A Breslin

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Gastroenteritis
  • Intestinal Diseases
  • Pediatric Diseases
  • Diarrhea, Infantile

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paul A Breslin on 2026-02-12.