Acute GastroenteritisPhase 1/2fORTNCT06137014
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
A Phase 1/2 study testing Fortified Oral Rehydration Therapy in people with Acute Gastroenteritis, run by Paul A Breslin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Fortified Oral Rehydration Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Allergy to any of the ingredients in the study products
- Inborn metabolic disorder of amino acids
- Receives post-pyloric feedings
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Paul AS Breslin, PhD, 848-932-6080, pasb@sebs.rutgers.edu
Payton Harmon, BS, 978-944-8484, payton.harmon@rutgers.edu
About this study
Official title: Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
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.
- Conditions
- Acute Gastroenteritis
- Being tested
- Fortified Oral Rehydration Therapy, Standard of Care Oral Rehydration Therapy
- Keywords
- Gastroenteritis, Intestinal Diseases, Pediatric Diseases, Diarrhea, Infantile
- Medical subject headings
- Gastroenteritis, Intestinal Diseases, Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified Oral Rehydration TherapyDrug
Also called FORT
Oral rehydration solution with reduced glucose and added amino acids.
Standard of Care Oral Rehydration TherapyDietary supplement
Glucose-based oral rehydration therapy according to World Health Organization guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Amino acid-fortified oral rehydration therapy | Experimental | 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) Receives: Drug: Fortified Oral Rehydration Therapy |
| Standard of care oral rehydration therapy | Placebo comparator | 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) Receives: Dietary Supplement: Standard of Care Oral Rehydration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Stool Frequency
Number of bowel movements (BMs) per day (count)
Measured: Up to 14 days
Daily Stool Mass
Total mass of stool per day from measured BMs in grams
Measured: Up to 14 days
Duration of Diarrhea
Duration of diarrhea in hours from onset until 3 formed stools in a row
Measured: Up to 14 days
Secondary outcomes (4)
Consumption of Study Intervention
Mls of ORT or FORT consumed per day
Measured: Up to 14 days
Stool Consistency
Stool consistency rated on the Bristol Stool Scale
Measured: Up to 14 days
Body Weight
Weight of child each day of study in kg
Measured: Up to 14 days
Stool Human Beta-Defensin-2 Content
Beta-defensin-2 measured from stool sample in ng/ml
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul A Breslin
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Sponsor-investigator, Paul A Breslin, Rutgers, The State University of New Jersey
- Investigators
- Paul Breslin, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137014
- Sponsor's protocol ID
- Pro2021002499
- Acronym
- fORT
- Status last verified
- Feb 2026
- First submitted
- 7 Nov 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all de-identified data upon request by other researchers upon submission of manuscripts to journals.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
- ClinicalTrials.gov ID
- NCT06137014
- Acronym / sponsor ID
- fORT / Pro2021002499
- Conditions
- Acute Gastroenteritis
- Keywords
- Gastroenteritis, Intestinal Diseases, Pediatric Diseases, Diarrhea, Infantile
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Paul A BreslinUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino acid-fortified oral rehydration therapy | Experimental | Drug: Fortified Oral Rehydration TherapyParticipants 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) |
| Standard of care oral rehydration therapy | Placebo comparator | Dietary Supplement: Standard of Care Oral Rehydration TherapyParticipants 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) |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Severe gastroenteritis with moderate to severe dehydration
- Requiring inpatient care
- Requiring antibiotics
- Requiring IV rehydration
- History of chronic diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortified Oral Rehydration TherapyAlso: FORTOral rehydration solution with reduced glucose and added amino acids. | Drug | Amino acid-fortified oral rehydration therapy |
| Standard of Care Oral Rehydration TherapyGlucose-based oral rehydration therapy according to World Health Organization guidelines. | Dietary supplement | Standard of care oral rehydration therapy |
Primary outcome
Daily Stool Frequency
Time frame: Up to 14 days
Number of bowel movements (BMs) per day (count)
Daily Stool Mass
Time frame: Up to 14 days
Total mass of stool per day from measured BMs in grams
Duration of Diarrhea
Time frame: Up to 14 days
Duration of diarrhea in hours from onset until 3 formed stools in a row
4 secondary outcomes
Consumption of Study Intervention
Time frame: Up to 14 days
Stool Consistency
Time frame: Up to 14 days
Body Weight
Time frame: Up to 14 days
Stool Human Beta-Defensin-2 Content
Time frame: Up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. We will share all de-identified data upon request by other researchers upon submission of manuscripts to journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Breslin, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fortified Oral Rehydration Therapy in people with Acute Gastroenteritis, run by Paul A Breslin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Breslin, PhD ((848) 932-6085, breslin@monell.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Stool Frequency (time frame: Up to 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.