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NCT06137014 · ClinicalTrials.gov registry record · Phase 1
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
A Phase 1 study of Acute Gastroenteritis, sponsored by Paul A Breslin.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT06137014: Recruiting Phase 1 study of Acute Gastroenteritis, sponsored by Paul A Breslin.
NCT06137014 is a Phase 1 study of Acute Gastroenteritis that is actively recruiting participants, run by Paul A Breslin. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06137014, a Phase 1 study of Acute Gastroenteritis, is actively recruiting participants, sponsored by Paul A Breslin.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of bowel movements (BMs) per day (count)
Conditions Studied
Interventions
- DRUG Fortified Oral Rehydration Therapy
- DIETARY_SUPPLEMENT Standard of Care Oral Rehydration Therapy
Study Locations (1)
New Jersey
- Robert Wood Johnson University Hospital - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT06137014 shows while recruiting
NCT06137014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Acute Gastroenteritis appearing as the primary indexed condition, and to 2 interventions - of which Fortified Oral Rehydration Therapy is the first listed.
NCT06137014 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06137014 about?
NCT06137014 is a clinical study titled "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 comp...
What is the current status of trial NCT06137014?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2024-06-01. Estimated completion is 2027-06.
What conditions does trial NCT06137014 study?
This clinical trial studies the following conditions: Acute Gastroenteritis.
What interventions are being tested in trial NCT06137014?
The interventions under investigation include: Fortified Oral Rehydration Therapy (DRUG), Standard of Care Oral Rehydration Therapy (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06137014?
This trial is sponsored by Paul A Breslin, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06137014 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06137014's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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