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

Phase 4

Completed

• Conditions: Diarrhea
• Interventions: Dietary Supplement: oral rehydration solution Hipp ORS Apple 200; Dietary Supplement: ESPGHAN ORS

• Registration Number: NCT01467570
• Lead Sponsor: Medical University of Warsaw

Brief 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).

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-11
• Results First Submitted: 2013-11-20
• Results First Submitted QC: 2014-02-14
• Last Update Submitted: 2014-02-14
• Results First Posted: 2014-04-01
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hipp ORS Apple 200	oral rehydration solution Hipp ORS Apple 200	oral rehydration solution Hipp ORS 200 Apple
ESPGHAN ORS	ESPGHAN ORS	ESPGHAN oral rehydration solution

Primary Outcome Measures

Name	Time	Method
Number of Participants That Were Successfully Rehydrated	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Peadiatrics, The Medical University of Warsaw; 🇵🇱 Warsaw, Poland