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NCT Number: NCT06137014

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

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.

Recruiting

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Key information

Conditions

Acute Gastroenteritis Diarrhea Diarrhea, Infantile Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fortified Oral Rehydration Therapy

Drug

Oral rehydration solution with reduced glucose and added amino acids.

Other names: FORT

Standard of Care Oral Rehydration Therapy

Dietary Supplement

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

Primary outcomes

  1. Daily Stool Frequency

    Time frame: Up to 14 days

    Number of bowel movements (BMs) per day (count)

  2. Daily Stool Mass

    Time frame: Up to 14 days

    Total mass of stool per day from measured BMs in grams

  3. Duration of Diarrhea

    Time frame: Up to 14 days

    Duration of diarrhea in hours from onset until 3 formed stools in a row

Secondary outcomes

  1. Consumption of Study Intervention

    Time frame: Up to 14 days

    Mls of ORT or FORT consumed per day

  2. Stool Consistency

    Time frame: Up to 14 days

    Stool consistency rated on the Bristol Stool Scale

  3. Body Weight

    Time frame: Up to 14 days

    Weight of child each day of study in kg

  4. Stool Human Beta-Defensin-2 Content

    Time frame: Up to 14 days

    Beta-defensin-2 measured from stool sample in ng/ml

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Breslin, PhD

CONTACT

[email protected]

(848) 932-6085

Payton Harmon

CONTACT

[email protected]

978-944-8484

Sponsors and collaborators

Lead sponsor

Paul A Breslin

Other

Collaborators

  • The Gerber Foundation

Registry information

Official study title

Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy

Acronym: fORT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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