Health TrialsbyHealthPanel

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

ConditionAcute Gastroenteritis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-5
SponsorPaul A Breslin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe gastroenteritis with moderate to severe dehydration

Requiring inpatient care

Requiring antibiotics

Requiring IV rehydration

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Amino acid-fortified oral rehydration therapyExperimental treatment 1 intervention
Group B: Standard of care oral rehydration therapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Daily Stool Frequency

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

Time frame
Up to 14 days
2

Daily Stool Mass

Total mass of stool per day from measured BMs in grams

Time frame
Up to 14 days
3

Duration of Diarrhea

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

Time frame
Up to 14 days

Secondary outcomes

1

Consumption of Study Intervention

Mls of ORT or FORT consumed per day

Time frame
Up to 14 days
2

Stool Consistency

Stool consistency rated on the Bristol Stool Scale

Time frame
Up to 14 days
3

Body Weight

Weight of child each day of study in kg

Time frame
Up to 14 days
4

Stool Human Beta-Defensin-2 Content

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

Time frame
Up to 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Paul A Breslin

Lead sponsor

Rutgers, The State University of New Jersey

Sponsor institution

The Gerber Foundation

Collaborator

Source ClinicalTrials.gov
Apply now