fORT: Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Sponsor

Paul Breslin, PhD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06137014

Collaborator

The Gerber Foundation (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Gastroenteritis	Drug: Fortified Oral Rehydration Therapy Dietary Supplement: Standard of Care Oral Rehydration Therapy	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amino acid-fortified oral rehydration therapy Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the 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)	Drug: Fortified Oral Rehydration Therapy Oral rehydration solution with reduced glucose and added amino acids. Other Names: FORT
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)	Dietary Supplement: Standard of Care Oral Rehydration Therapy Glucose-based oral rehydration therapy according to World Health Organization guidelines.

Arm

Intervention/Treatment

Experimental: Amino acid-fortified oral rehydration therapy

Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the 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)

Drug: Fortified Oral Rehydration Therapy

Oral rehydration solution with reduced glucose and added amino acids.

Other Names:

FORT

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)

Dietary Supplement: Standard of Care Oral Rehydration Therapy

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

Outcome Measures

Primary Outcome Measures

Daily Stool Frequency [Up to 14 days]
Number of bowel movements (BMs) per day (count)
Daily Stool Mass [Up to 14 days]
Total mass of stool per day from measured BMs in grams
Duration of Diarrhea [Up to 14 days]
Duration of diarrhea in hours from onset until 3 formed stools in a row

Secondary Outcome Measures

Consumption of Study Intervention [Up to 14 days]
Mls of ORT or FORT consumed per day
Stool Consistency [Up to 14 days]
Stool consistency rated on the Bristol Stool Scale
Body Weight [Up to 14 days]
Weight of child each day of study in kg
Stool Human Beta-Defensin-2 Content [Up to 14 days]
Beta-defensin-2 measured from stool sample in ng/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Paul Breslin, PhD
The Gerber Foundation

Investigators

Principal Investigator: Paul Breslin, PhD, Rutgers, The State University of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul Breslin, PhD, Professor of Nutritional Sciences, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT06137014

Other Study ID Numbers:

Pro2021002499

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Paul Breslin, PhD, Professor of Nutritional Sciences, Rutgers, The State University of New Jersey

Additional relevant MeSH terms:

Gastroenteritis

Study Results

No Results Posted as of Nov 18, 2023