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

Diarrhea Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01467570
Study type Interventional
Source Medical University of Warsaw
Contact
Status Completed
Phase Phase 4
Start date June 2009
Completion date December 2011
View Details
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