Clinical trial NCT01467570: Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Keywords: diarrhea
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 147
Sex: ALL
Minimum age (years): 4
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants That Were Successfully Rehydrated
timeFrame: Proportion of successfully rehydrated at 24 hours
Secondary outcomes:
measure: Unscheduled Intravenous Therapy
timeFrame: 24 hours
measure: Vomiting
timeFrame: 24 hours
measure: ORS Intake in ml
timeFrame: 24 hours
measure: Weight Gain in Gram
timeFrame: 24 hours
measure: Duration of Diarrhea (Hrs)
timeFrame: 7days
measure: Return Visit to the Emergency Department
timeFrame: 1 week
measure: Hospitalization
timeFrame: 1 week
measure: Adverse Events
timeFrame: 24 hours
measure: ORS Intake at 4 h
timeFrame: 4 hrs
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Peadiatrics, The Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Hania Szajewska, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.