NCT01467570

Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis

Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis: Randomized, Double-Blind Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 4 Months – 48 Months
• Healthy volunteers: Not accepted

Summary

It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended treatment. The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN in children with acute gastroenteritis (AGE).

Detailed description

It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Despite the proven efficacy of oral rehydration therapy it remains underused. The main reason for this is that an ORS neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness, which decreases its acceptance. Moreover, unpalatability of regular ORS decrease its acceptance, especially in children with lower degrees of dehydration. Refusal to drink regular ORS interfere with compliance with the recommended treatment. Parents, but also health care professionals, demand safe, effective, inexpensive, but also well tolerated and accepted ORS for management of AGE. Recently, a new ORS (Hipp ORS 200 Apple) with improved taste has been developed, and is now frequently employed for the management of AGE. The proposed study will be the first double-blind randomized trial of this ORS. It will evaluate clinically meaningful benefits to be derived by children and caregivers from its use. If positive, this new ORS may become a routine recommendation for children with AGE. The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) with regular ORS recommended by ESPGHAN in children with AGE.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral rehydration solution Hipp ORS Apple 200	Volume of the solution calculated by weight: * fast oral rehydration in 3-4 hours by mouth * ORS given for ongoing losses until diarrhea stops (maintenance phase)
DIETARY_SUPPLEMENT	ESPGHAN ORS	Volume of the solution calculated by weight: * fast oral rehydration in 3-4 hours by mouth * ORS given for ongoing losses until diarrhea stops (maintenance phase)

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-11-08
• Last updated: 2014-04-01
• Results posted: 2014-04-01

Locations

1 site across 1 country: Poland