Fortified Oral Rehydration Therapy for Pediatric Diarrhea (fORT)

Paul A Breslin

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Acute Gastroenteritis

Treatments: Drug: Fortified Oral Rehydration Therapy; Dietary Supplement: Standard of Care Oral Rehydration Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06137014

Pro2021002499

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

Amino acid-fortified oral rehydration therapy

Experimental group

Description:

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)

Treatment:

Drug: Fortified Oral Rehydration Therapy

Standard of care oral rehydration therapy

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Standard of Care Oral Rehydration Therapy