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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

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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).

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Detailed Description

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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

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hipp ORS Apple 200

oral rehydration solution Hipp ORS 200 Apple

Group Type EXPERIMENTAL

oral rehydration solution Hipp ORS Apple 200

Intervention Type DIETARY_SUPPLEMENT

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)

ESPGHAN ORS

ESPGHAN oral rehydration solution

Group Type ACTIVE_COMPARATOR

ESPGHAN ORS

Intervention Type DIETARY_SUPPLEMENT

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)

Interventions

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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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

4 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No