Sucrose Solution for Pediatric Gastroenteritis

(STAGE Trial)

Overseen By Jocelyn Gravel, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Jocelyn Gravel

Disqualifiers: Severe dehydration, Hypoglycemia, Chronic disease, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a sucrose (sugar) solution can help young children with suspected viral gastroenteritis (a type of stomach flu) consume more rehydration fluids. The study compares the effects of a sucrose solution to regular diluted juice on hydration and symptoms like vomiting. It also examines how quickly children can be discharged from the emergency department and whether they need to return within 48 hours. Children aged 6 months to 6 years who have vomited at least three times in the last 24 hours and show signs of acute viral gastroenteritis may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to enhance understanding of effective hydration methods for young children.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that sucrose solutions are generally safe and effective for children. One study found that only 10% of children given a sucrose solution had a poor response, compared to 27% of those given glucose, suggesting sucrose might be easier for children to handle. Another study found that sweet solutions, such as those with sucrose, are safe and can help calm infants after vaccinations. These findings suggest that sucrose solutions are usually well-tolerated by children, although individual responses can differ. Prospective trial participants should consult a doctor about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a sucrose solution to treat pediatric gastroenteritis because it offers a simple, natural approach that might quickly ease symptoms. Unlike traditional treatments that often focus on rehydration with electrolyte solutions, this method uses a homemade mix of table sugar and juice to potentially provide fast relief. The idea is that the sucrose could help reduce vomiting and diarrhea by soothing the stomach. Plus, it’s an easy and affordable option that could be adopted in many settings, making it an attractive alternative to more complex treatments.

What evidence suggests that sucrose solution might be an effective treatment for pediatric gastroenteritis?

Research has shown that sugar-water solutions can help manage symptoms of stomach flu in young children. In this trial, one group will receive a sucrose solution, a type of sugar-water solution. Previous studies found that children who drank a sugar-water solution experienced fewer treatment failures (10%) compared to those who drank a glucose solution (27%). Another study found that sugar-electrolyte drinks worked as effectively as glucose-electrolyte drinks for treating stomach flu in infants. These findings suggest that adding sugar to rehydration drinks could help children better manage vomiting and dehydration caused by stomach flu. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 6 months to 6 years who have had at least three episodes of non-bilious, non-bloody vomiting in the past day and are suspected of having acute viral gastroenteritis. It excludes those with severe dehydration, bilious or bloody vomiting, previous study participation, chronic diseases (except asthma), hypoglycemia, or if parental consent cannot be obtained.

Inclusion Criteria

No other diagnostic more likely than acute viral gastroenteritis suspected at triage

My child is between 6 months and 6 years old.

I have vomited at least 3 times in the last day without blood or bile.

Exclusion Criteria

Inability to obtain parental informed consent (language barrier, absence, etc.)

I have a chronic condition that is not asthma.

Previous inclusion in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Immediate

1 visit (in-person)

Intervention

Participants receive either a sucrose solution or a placebo at triage

2 hours

1 visit (in-person)

Observation

Participants are monitored for oral rehydration success and other outcomes

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for return visits and other outcomes post-discharge

48 hours

What Are the Treatments Tested in This Trial?

Interventions

• Sucrose

Trial Overview The trial tests whether giving a sucrose solution (1.5 ml/kg) made from diluted juice with added sugar helps young children with gastroenteritis absorb more rehydration solution within two hours compared to standard care. This double-blind randomized controlled trial will measure intake of rehydration fluids and other outcomes like discharge rates and return visits.

How Is the Trial Designed?

Group I: Sucrose Experimental Treatment 1 Intervention

The experimental arm will receive 1.5 ml/kg of the sucrose solution at triage (once). The composition of the homemade sucrose solution used in our emergency department is 3.5 g of table sugar (sucrose) mixed with 10 ml of diluted juice (see standard arm description) to obtain a solution with the same appearance as the standard arm.

Group II: Control Placebo Group 1 Intervention

This group will receive 1.5 mL/kg of diluted juice composed of juice (apple or orange) and water in equal proportion once at triage. This solution contains 0.05 g/ml of sucrose for a total of 0.075 g/kg of sucrose (eight times less than the intervention arm).

Who Is Running the Clinical Trial?

Jocelyn Gravel

Lead Sponsor

Trials

1

Recruited

240+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/944022/

Clinical comparison between glucose and sucrose ... Of the children treated with added sucrose 10% failed to respond compared with 27% of those treated with added glucose. This difference was significant (P=0-05) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2130130/

Comparison of oral sucrose and glucose electrolyte ... Sucrose-electrolyte solution is at least as effective as a glucose-electrolyte solution for the out-patient management of acute gastroenteritis in infancy.

3. withpower.com withpower.com/trial/phase-gastroenteritis-4-2022-fc83b

Sucrose Solution for Pediatric Gastroenteritis (STAGE Trial) Objective: The aim of this study is to assess the impact of providing a sucrose solution at triage to young children with suspected acute viral gastroenteritis ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022347680803179

A comparison of sucrose and glucose electrolyte solutions We performed a double-blind trial comparing sucrose electrolyte oral solution with glucose electrolyte oral solution in children less than 5 years of age ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05378776/sucrose-at-triage-for-acute-gastroenteritis-episode-in-children

Sucrose at Triage for Acute Gastroenteritis Episode in ... Objective: The aim of this study is to assess the impact of providing a sucrose solution at triage to young children with suspected acute viral ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4253236/

A Comparative Study on the Efficacy of Glucose and ... Another study in 2007revealed that Sweet solution can be used as a simple and safe method to reduce the distress following vaccination in infants [12].

7. researchgate.net researchgate.net/publication/15761619_Oral_Solutions_for_infantile_gastroenteritis-variations_in_composition

(PDF) Oral Solutions for infantile gastroenteritis–variations ... Four different carbohydrate electrolyte solutions were provided for children under 18 months with acute gastroenteritis treated as outpatients.