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

Study Overview
=================
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.

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

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Dietary Supplement: oral rehydration solution Hipp ORS Apple 200
* Dietary Supplement: ESPGHAN ORS


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 48 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hipp ORS Apple 200<br>oral rehydration solution Hipp ORS 200 Apple | Dietary Supplement: oral rehydration solution Hipp ORS Apple 200<br>* 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)<br>|
| Active Comparator: ESPGHAN ORS<br>ESPGHAN oral rehydration solution | Dietary Supplement: ESPGHAN ORS<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Proportion of successfully rehydrated at 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diarrhea