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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new type of oral rehydration therapy (ORT) with added amino acids can better assist children with acute gastroenteritis (a stomach and intestinal infection) compared to the usual treatment. Researchers aim to determine if the fortified ORT can reduce the duration and severity of illness in children. They also seek to assess whether it enhances certain beneficial substances in the gut. Eligible participants are children aged 6 months to 5 years who have experienced mild to moderate diarrhea for less than two days. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking medical advancements.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fortified oral rehydration therapy (ORT) is generally easy for people to handle. A review of 14 studies found no major difference in the effectiveness of fortified ORT compared to standard ORT, indicating that adding amino acids does not compromise safety.

Additionally, studies on similar treatments, such as zinc-fortified ORT, have demonstrated safety for children and have been used frequently without major issues. Although researchers are still studying amino acid-fortified ORT, early results suggest it is safe for children with stomach and intestine infections. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the amino acid-fortified oral rehydration therapy (fORT) because, unlike the standard oral rehydration solutions typically used for pediatric gastroenteritis, this treatment includes amino acids, which may enhance fluid absorption and retention. By potentially improving hydration more effectively, it could help children recover faster from dehydration caused by diarrhea. This novel approach targets the body's ability to absorb water more efficiently, offering a promising advancement over traditional rehydration solutions.

What evidence suggests that amino acid-fortified oral rehydration therapy could be effective for pediatric gastroenteritis?

This trial will compare standard oral rehydration therapy with an amino acid-fortified version. Research has shown that adding amino acids to oral rehydration therapy (ORT) might help treat sudden stomach bugs in children. Early results suggest that this enhanced ORT could shorten the duration and lessen the severity of diarrhea. Amino acids improve the body's absorption of fluids and essential salts, which is crucial for maintaining hydration. Studies on similar treatments have demonstrated that children recover faster and maintain better hydration. While more research is needed, these early findings offer hope for children with stomach bugs. ^{1 3 4 6 7}

Who Is on the Research Team?

Paul Breslin, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06137014

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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06137014/fortified-oral-rehydration-therapy-for-pediatric-diarrhea

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10773804/

Acute gastroenteritis—changes to the recommended ... The World Health Organization recommended a formulation of oral rehydration salts as the intervention of choice for the treatment of acute gastroenteritis.

4. cdc.gov cdc.gov/mmwr/preview/mmwrhtml/rr5216a1.htm

Managing Acute Gastroenteritis Among Children The efficacy and safety of a zinc-fortified (40 mg/L) ORS among 1,219 children with acute diarrhea was evaluated (87). Compared with zinc syrup administered at ...

5. publications.aap.org publications.aap.org/pediatricsinreview/article/46/7/355/202406/Oral-Rehydration-Salt-Solutions-for-Children-A

Oral Rehydration Salt Solutions for Children: A Review Oral rehydration salts (ORS) solutions can successfully treat mild to moderate dehydration. However, the uptake of this simple and cost-effective intervention ...

6. withpower.com withpower.com/trial/phase-2-gastroenteritis-11-2023-3c2fa

Fortified Oral Rehydration Therapy for Pediatric ... A systematic review of 14 randomized controlled trials found no significant difference in treatment failure rates between oral rehydration therapy (ORT) and ...

7. trialx.com trialx.com/clinical-trials/listings/292935/fortified-oral-rehydration-therapy-for-pediatric-diarrhea/

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 ...