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

Medical University of Warsaw

Status and phase

Completed

Phase 4

Conditions

Diarrhea

Treatments

Dietary Supplement: oral rehydration solution Hipp ORS Apple 200

Dietary Supplement: ESPGHAN ORS

Study type

Interventional

Funder types

Other

Identifiers

NCT01467570

KB/191/2008

Details and patient eligibility

About

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).

Full 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.

Enrollment

147 patients

Sex

All

Ages

4 to 48 months old

Volunteers

No Healthy Volunteers

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