- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01467570
Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis
Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis: Randomized, Double-Blind Controlled Trial
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Warsaw, Poland, 01-183
- Department of Peadiatrics, The Medical University of Warsaw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Hipp ORS Apple 200
oral rehydration solution Hipp ORS 200 Apple
|
Volume of the solution calculated by weight:
|
ACTIVE_COMPARATOR: ESPGHAN ORS
ESPGHAN oral rehydration solution
|
Volume of the solution calculated by weight:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants That Were Successfully Rehydrated
Time Frame: Proportion of successfully rehydrated at 24 hours
|
The following components are included in primary outcome:
|
Proportion of successfully rehydrated at 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unscheduled Intravenous Therapy
Time Frame: 24 hours
|
Need for intravenous therapy within 24 hours
|
24 hours
|
Vomiting
Time Frame: 24 hours
|
Vomiting starting or progressing in the first 24 hours of therapy
|
24 hours
|
ORS Intake in ml
Time Frame: 24 hours
|
ORS intake in ml (in the first 24 hours, and total)
|
24 hours
|
Weight Gain in Gram
Time Frame: 24 hours
|
Weight gain in gram (in the first 24 hours, and total)
|
24 hours
|
Duration of Diarrhea (Hrs)
Time Frame: 7days
|
Time of diarrhea in hours
|
7days
|
Return Visit to the Emergency Department
Time Frame: 1 week
|
Return visit to the emergency department within a week
|
1 week
|
Hospitalization
Time Frame: 1 week
|
need for hospitalization within a week
|
1 week
|
Adverse Events
Time Frame: 24 hours
|
any adverse event, providing a description if related or not related to study intervention
|
24 hours
|
ORS Intake at 4 h
Time Frame: 4 hrs
|
% of prescribed ORS that was consumed during first 4 hours
|
4 hrs
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hania Szajewska, Professor, Medical University of Warsaw
Publications and helpful links
General Publications
- Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available.
- Recommendations for composition of oral rehydration solutions for the children of Europe. Report of an ESPGAN Working Group. J Pediatr Gastroenterol Nutr. 1992 Jan;14(1):113-5. No abstract available.
- Szajewska H, Hoekstra JH, Sandhu B; ESPGHAN Working Group on Acute Diarrhoea. Management of acute gastroenteritis in Europe and the impact of the new recommendations: a multicenter study. The Working Group on acute Diarrhoea of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2000 May;30(5):522-7. doi: 10.1097/00005176-200005000-00011.
- Piescik-Lech M, Szymanski H, Szajewska H. Efficacy and safety of a new apple-flavoured oral rehydration solution in children with acute gastroenteritis: a double-blind randomized controlled trial. Acta Paediatr. 2012 Oct;101(10):e458-64. doi: 10.1111/j.1651-2227.2012.02782.x. Epub 2012 Aug 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KB/191/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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