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

This study is currently recruiting participants.
Verified November 2011 by Medical University of Warsaw
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01467570
First received: October 27, 2011
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Diarrhea
 Dietary Supplement: oral rehydration solution Hipp ORS Apple 200
Dietary Supplement: ESPGHAN ORS
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Proportion of successfully rehydrated [ Time Frame: Proportion of successfully rehydrated at 24 hours ] [ Designated as safety issue: No ]

    The following components are included in primary outcome:

    • resolution of signs of dehydration
    • adequate weight gain
    • production of urine output during the trial


Secondary Outcome Measures:
  • Unscheduled intravenous therapy [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Need for intravenous therapy

  • Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Vomiting starting or progressing in the first 24 hours of therapy

  • ORS intake in ml [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    ORS intake in ml (in the first 24 hours, and total)

  • Weight gain in gram [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Weight gain in gram (in the first 24 hours, and total)

  • Duration of diarrhea (hrs) [ Time Frame: 7days ] [ Designated as safety issue: No ]
    Time of diarrhea in hours

  • Return visit to the emergency department [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Return visit to the emergency department within a week

  • Hospitalization [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    any adverse event, providing a description if related or not related to study intervention


Estimated Enrollment: 147
Study Start Date: June 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hipp ORS Apple 200
oral rehydration solution Hipp ORS 200 Apple
 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)
Active Comparator: ESPGHAN ORS
ESPGHAN oral rehydration solution
 Dietary Supplement: 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)

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

Ages Eligible for Study:   4 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467570

Contacts
Contact: Hania Szajewska, Professor +48224523309 hania@ipgate.pl
Contact: Malgorzata Piescik-Lech, MD +48224523274 gosik81@wp.pl

Locations
Poland
Department of Peadiatrics, The Medical University of Warsaw Recruiting
Warsaw, Poland, 01-183
Contact: Malgorzata Piescik-Lech, MD     +48224523274     gosik81@wp.pl    
Sub-Investigator: Malgorzata Piescik-Lech, MD            
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Principal Investigator: Hania Szajewska, Professor The Medical University of Warsaw, Poland
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01467570     History of Changes
Other Study ID Numbers: KB/191/2008
Study First Received: October 27, 2011
Last Updated: November 3, 2011
Health Authority: Poland: Ethics Committee
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: National Institute of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials

Keywords provided by Medical University of Warsaw:
diarrhea

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
 Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013