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Sucrose Solution for Pediatric Gastroenteritis (STAGE Trial)

N/A

Recruiting

Research Sponsored by Jocelyn Gravel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 3 non-bilious, non-bloody vomiting episodes in the last 24 hours

Be younger than 18 years old

Must not have

Bilious or bloody vomiting

Severe dehydration (based on poor capillary refill or hypotension)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Summary

This trial will assess the impact of providing a sucrose solution at triage to young children with suspected acute viral gastroenteritis on the amount of rehydration solution intake in the first 2 hours.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from taste differences between the sucrose solution and standard rehydration fluid. However, since both interventions involve common dietary components (sucrose and juice), significant side effects are not anticipated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been vomiting bile or blood.

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I am not severely dehydrated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean amount of tolerated oral rehydration in mL

Secondary study objectives

Mean length of stay

Mean length of stay after physician evaluation

Mean number of vomiting

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SucroseExperimental Treatment1 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: ControlPlacebo Group1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

sucrose

2010

Completed Phase 2

~1290

0 / 3Eligibility criteria met