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

Medical University of Warsaw147 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diarrhea

Interventions

oral rehydration solution Hipp ORS Apple 200DIETARY_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 ORSDIETARY_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)

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 48 Months

Medical Language ↔ Plain English

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

Locations (1)

Department of Peadiatrics, The Medical University of Warsaw

Warsaw, Poland

Outcomes

Primary Outcomes

Number of Participants That Were Successfully Rehydrated

The following components are included in primary outcome: * resolution of signs of dehydration * adequate weight gain * production of urine output during the trial

Time frame: Proportion of successfully rehydrated at 24 hours

Secondary Outcomes

Unscheduled Intravenous Therapy

Need for intravenous therapy within 24 hours

Time frame: 24 hours

Vomiting

Vomiting starting or progressing in the first 24 hours of therapy

Time frame: 24 hours

ORS Intake in ml

ORS intake in ml (in the first 24 hours, and total)

Time frame: 24 hours

Weight Gain in Gram

Weight gain in gram (in the first 24 hours, and total)

Time frame: 24 hours

Duration of Diarrhea (Hrs)

Time of diarrhea in hours

Time frame: 7days

Return Visit to the Emergency Department

Return visit to the emergency department within a week

Time frame: 1 week

Hospitalization

need for hospitalization within a week

Time frame: 1 week

Adverse Events

Data from ClinicalTrials.gov

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