Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Conditions

• Acute Gastroenteritis

Eligibility Criteria

Sex

ALL

Age

6 Months - 5 Years

Healthy Volunteers

Not accepted

Interventions

• Fortified Oral Rehydration Therapy — DRUG
  Oral rehydration solution with reduced glucose and added amino acids.
• Standard of Care Oral Rehydration Therapy — DIETARY_SUPPLEMENT
  Glucose-based oral rehydration therapy according to World Health Organization guidelines.

Study Details

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.

Key Dates

Start date

Jun 1, 2024

Status verified

Feb 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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)

Primary Outcome Measure

Daily Stool Frequency [ Time Frame: Up to 14 days ]

Central Contacts

• Paul Breslin, PhD
  (848) 932-6085
  [email protected]
• Payton Harmon
  978-944-8484
  [email protected]

Locations (1)

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