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

February 14, 2014 updated by: Medical University of Warsaw

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

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).

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Warsaw, Poland, 01-183
        • Department of Peadiatrics, The Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children age 4 to 48 months
  • diarrhoea defined as the passage of three or more loose or watery stools per day for >1 but <5 days
  • mild (3%) or moderate dehydration (3-9%) according to the World Health Organization criteria (Table 1)
  • informed consent signed by at least one parent / caregiver

Exclusion Criteria:

  • diarrhea for <1 or >5 days
  • severe dehydration (>9%)
  • recent history of diarrhea indicated either by parent/guardian or hospital case notes
  • underlying chronic gastrointestinal disease (i.e., celiac disease, cow's milk protein intolerance)
  • breastfeeding >50%
  • under nutrition (weight/height ratio below the fifth percentile)
  • systemic infections
  • immune defects or immunosuppressive treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hipp ORS Apple 200
oral rehydration solution Hipp ORS 200 Apple

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)
ACTIVE_COMPARATOR: ESPGHAN ORS
ESPGHAN oral rehydration solution

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Were Successfully Rehydrated
Time Frame: Proportion of successfully rehydrated at 24 hours

The following components are included in primary outcome:

  • resolution of signs of dehydration
  • adequate weight gain
  • production of urine output during the trial
Proportion of successfully rehydrated at 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unscheduled Intravenous Therapy
Time Frame: 24 hours
Need for intravenous therapy within 24 hours
24 hours
Vomiting
Time Frame: 24 hours
Vomiting starting or progressing in the first 24 hours of therapy
24 hours
ORS Intake in ml
Time Frame: 24 hours
ORS intake in ml (in the first 24 hours, and total)
24 hours
Weight Gain in Gram
Time Frame: 24 hours
Weight gain in gram (in the first 24 hours, and total)
24 hours
Duration of Diarrhea (Hrs)
Time Frame: 7days
Time of diarrhea in hours
7days
Return Visit to the Emergency Department
Time Frame: 1 week
Return visit to the emergency department within a week
1 week
Hospitalization
Time Frame: 1 week
need for hospitalization within a week
1 week
Adverse Events
Time Frame: 24 hours
any adverse event, providing a description if related or not related to study intervention
24 hours
ORS Intake at 4 h
Time Frame: 4 hrs
% of prescribed ORS that was consumed during first 4 hours
4 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hania Szajewska, Professor, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (ESTIMATE)

November 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2014

Last Update Submitted That Met QC Criteria

February 14, 2014

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KB/191/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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