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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01467570
First received: October 27, 2011
Last updated: February 14, 2014
Last verified: November 2013
  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:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Number of Participants That Were 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 within 24 hours

  • 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 ]
    need for hospitalization within a week

  • 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

  • ORS Intake at 4 h [ Time Frame: 4 hrs ] [ Designated as safety issue: No ]
    % of prescribed ORS that was consumed during first 4 hours


Enrollment: 147
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467570

Locations
Poland
Department of Peadiatrics, The Medical University of Warsaw
Warsaw, Poland, 01-183
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
Results First Received: November 20, 2013
Last Updated: February 14, 2014
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
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014