Status:
COMPLETED
Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis
Lead Sponsor:
Medical University of Warsaw
Conditions:
Diarrhea
Eligibility:
All Genders
4-48 years
Phase:
PHASE4
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 Rehyd...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT01467570
Start Date
June 1 2009
End Date
December 1 2011
Last Update
April 1 2014
Active Locations (1)
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1
Department of Peadiatrics, The Medical University of Warsaw
Warsaw, Poland, 01-183