Fortified Oral Rehydration Therapy for Pediatric Gastroenteritis

(fORT Trial)

Overseen By Payton Harmon

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Paul A Breslin

Must not be taking: Antibiotics

Disqualifiers: Severe dehydration, Chronic diarrhea, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 weeks

72 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Fortified Oral Rehydration Therapy for pediatric gastroenteritis?

Research shows that oral rehydration therapy (ORT) is recommended for treating dehydration in children with gastroenteritis, and it is effective and safe according to various studies. Although ORT is underused, it is supported by organizations like the American Academy of Pediatrics for managing mild to moderate dehydration in children. ^{1 2 3 4 5}

Is Fortified Oral Rehydration Therapy safe for children?

Research shows that oral rehydration therapy (ORT) is generally safe for children with gastroenteritis, as it is recommended by the American Academy of Pediatrics for mild to moderate dehydration. ^{1 3 4 5 6}

How is Fortified Oral Rehydration Therapy different from other treatments for pediatric gastroenteritis?

Fortified Oral Rehydration Therapy is unique because it includes amino acids, which may enhance the absorption of fluids and electrolytes compared to standard oral rehydration solutions. This could potentially make it more effective in treating dehydration caused by gastroenteritis in children. ^{1 2 3 4 7}

Research Team

Paul Breslin, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Eligibility Criteria

This trial is for children aged 6 months to 5 years with mild to moderate stomach flu, who've been sick for less than two days. It's not suitable for kids outside this age range or those with non-infectious diarrhea causes.

Inclusion Criteria

I am between 6 months and 5 years old.

I've had stomach flu symptoms for less than 2 days.

You have diarrhea that is believed to be caused by an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either amino acid-fortified ORT or standard of care ORT for acute gastroenteritis

Up to 2 weeks

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Fortified Oral Rehydration Therapy

Trial Overview The study compares a new amino acid-fortified oral rehydration solution against the usual treatment in young patients with gastroenteritis. It checks if the new solution can shorten illness and boost gut defenses better than standard therapy.

Participant Groups

Group I: Amino acid-fortified oral rehydration therapy Experimental Treatment 1 Intervention

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)

Group II: Standard of care oral rehydration therapy Placebo Group 1 Intervention

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)

Fortified Oral Rehydration Therapy is already approved in European Union, United States for the following indications:

Approved in European Union as Oral Rehydration Therapy for:

• Acute gastroenteritis
• Pediatric diarrhea

Approved in United States as Oral Rehydration Therapy for:

• Acute gastroenteritis
• Pediatric diarrhea

Who Is Running the Clinical Trial?

Paul A Breslin

Lead Sponsor

Trials

1

Recruited

70+

Paul Breslin, PhD

Lead Sponsor

Trials

1

Recruited

70+

The Gerber Foundation

Collaborator

Trials

45

Recruited

6,200+

Findings from Research

A survey of 60 Pediatric Emergency Medicine fellowship program directors revealed that despite all having experience and knowledge about oral rehydration therapy (ORT), only 17.2% believe it is better than intravenous (i.v.) rehydration in all scenarios, leading to underuse of ORT compared to AAP recommendations.

Key barriers to ORT use include the additional time required for administration (76.7%) and parental expectations for i.v. rehydration (41.7%), indicating that improving acceptance and understanding of ORT in emergency settings may enhance its utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral versus intravenous: rehydration preferences of pediatric emergency medicine fellowship directors. Conners, GP., Barker, WH., Mushlin, AI., et al.[2019]

A systematic review of 14 randomized controlled trials found no significant difference in treatment failure rates between oral rehydration therapy (ORT) and intravenous therapy (IVT) for treating dehydration in children with acute gastroenteritis, supporting the use of ORT as a first-line treatment.

ORT resulted in a shorter hospital stay compared to IVT, and while both treatments had some risks (like phlebitis with IVT and paralytic ileus with ORT), the overall efficacy and safety profiles were similar, reinforcing current guidelines that recommend ORT for dehydration management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials. Bellemare, S., Hartling, L., Wiebe, N., et al.[2022]

Oral rehydration therapy (ORT) is highly effective and safe for treating young children with gastroenteritis, with a low failure rate of only 3.6%, meaning very few children need intravenous rehydration.

There is no significant difference in the effectiveness of high-sodium versus low-sodium oral rehydration solutions, and ORT does not increase the risk of electrolyte imbalances compared to intravenous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of glucose-based oral rehydration therapy. Gavin, N., Merrick, N., Davidson, B.[2013]

In a study involving 60 children aged 3 to 72 months with acute gastroenteritis, the addition of gelatin tannate to oral rehydration therapy significantly reduced the number of bowel movements at 72 hours compared to oral rehydration alone.

The ORS plus gelatin tannate group also experienced a shorter duration of diarrhea and improved stool consistency, with no reported adverse events, indicating both efficacy and safety of this combined treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gelatin Tannate for Acute Childhood Gastroenteritis: A Randomized, Single-Blind Controlled Trial. Mennini, M., Tolone, C., Frassanito, A., et al.[2018]

A quality improvement initiative provided ORT kits and instructions to caregivers of children with acute gastroenteritis, resulting in over 90% of children receiving these kits during the intervention period.

Despite the successful distribution of ORT materials, caregiver self-reported adherence to oral rehydration therapy post-discharge did not improve, likely due to already high baseline adherence levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intervention to Improve Caregiver Adherence to Oral Rehydration Therapy. Sundberg, MJ., Parver, S., Morin, M., et al.[2022]

Oral rehydration therapy (ORT) is as effective as intravenous fluid therapy (IVF) for rehydrating moderately dehydrated children due to gastroenteritis, with similar success rates in a study of 73 patients.

ORT allows for quicker initiation of treatment (19.9 minutes vs. 41.2 minutes for IVF) and results in fewer hospitalizations (30.6% for ORT vs. 48.7% for IVF), making it a preferred option for managing dehydration in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral versus intravenous rehydration of moderately dehydrated children: a randomized, controlled trial. Spandorfer, PR., Alessandrini, EA., Joffe, MD., et al.[2022]

A systematic review of 55 studies across 23 countries identified key factors that facilitate the successful implementation of oral rehydration therapy (ORT) in low- and middle-income countries, including the availability and accessibility of ORT, community awareness and education, strong partnerships, and adaptable program designs.

Despite the effectiveness of ORT in treating diarrheal diseases, barriers such as limited access and knowledge hinder its widespread use, indicating that targeted implementation strategies informed by local contexts are essential for improving ORT coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to implementation of oral rehydration therapy in low- and middle-income countries: A systematic review. Ezezika, O., Ragunathan, A., El-Bakri, Y., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral versus intravenous: rehydration preferences of pediatric emergency medicine fellowship directors. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of glucose-based oral rehydration therapy. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Gelatin Tannate for Acute Childhood Gastroenteritis: A Randomized, Single-Blind Controlled Trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

An Intervention to Improve Caregiver Adherence to Oral Rehydration Therapy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Oral versus intravenous rehydration of moderately dehydrated children: a randomized, controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to implementation of oral rehydration therapy in low- and middle-income countries: A systematic review. [2021]