Phase 4
N=147
Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis
Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT01467570 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Number of Participants That Were Successfully Rehydrated — 57; 49 Participants — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- oral rehydration solution Hipp ORS Apple 200 (Dietary_supplement); ESPGHAN ORS (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Medical University of Warsaw
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Were Successfully Rehydrated |
57; 49 | 0.28 |
| SECONDARY Unscheduled Intravenous Therapy |
3; 5 | — |
| SECONDARY Vomiting |
0; 0 | — |
| SECONDARY ORS Intake in ml |
52.4; 50.2 | — |
| SECONDARY Weight Gain in Gram |
97; 123 | — |
| SECONDARY Duration of Diarrhea (Hrs) |
69.1; 61.9 | — |
| SECONDARY Return Visit to the Emergency Department |
0; 0 | — |
| SECONDARY Hospitalization |
3; 5 | — |
| SECONDARY Adverse Events |
0; 0 | — |
| SECONDARY ORS Intake at 4 h |
33.6; 33.2 | — |
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).
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
- 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
Data sourced from ClinicalTrials.gov (NCT01467570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.