MedTrace Logo

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

NCT01467570 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2014-04-01

Study results available
· View outcomes & findings →

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).

Conditions

Interventions

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)

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Hania Szajewska, Professor · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01467570 on ClinicalTrials.gov