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

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467570
• Other study ID #: KB/191/2008
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2011
• Last updated: February 14, 2014
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2013
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics CommitteePoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: National Institute of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: The Central Register of Clinical Trials
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 48 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Gastroenteritis

Intervention

Dietary Supplement:
• oral rehydration solution Hipp ORS Apple 200
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)
• ESPGHAN ORS
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)

Locations

Country	Name	City	State
Poland	Department of Peadiatrics, The Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View Citation

Szajewska H, Hoekstra JH, Sandhu B. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Unscheduled Intravenous Therapy	Need for intravenous therapy within 24 hours	24 hours	No
Secondary	Vomiting	Vomiting starting or progressing in the first 24 hours of therapy	24 hours	Yes
Secondary	ORS Intake in ml	ORS intake in ml (in the first 24 hours, and total)	24 hours	No
Secondary	Weight Gain in Gram	Weight gain in gram (in the first 24 hours, and total)	24 hours	No
Secondary	Duration of Diarrhea (Hrs)	Time of diarrhea in hours	7days	No
Secondary	Return Visit to the Emergency Department	Return visit to the emergency department within a week	1 week	No
Secondary	Hospitalization	need for hospitalization within a week	1 week	No
Secondary	Adverse Events	any adverse event, providing a description if related or not related to study intervention	24 hours	Yes
Secondary	ORS Intake at 4 h	% of prescribed ORS that was consumed during first 4 hours	4 hrs	No