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Completed

NCT Number: NCT01467570

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

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).

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Peadiatrics, The Medical University of Warsaw

Warsaw, 01-183, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral rehydration solution Hipp ORS Apple 200

Dietary Supplement

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

Dietary Supplement

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)

Primary outcomes

  1. Number of Participants That Were Successfully Rehydrated

    Time frame: Proportion of successfully rehydrated at 24 hours

    The following components are included in primary outcome:

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

Secondary outcomes

  1. Unscheduled Intravenous Therapy

    Time frame: 24 hours

    Need for intravenous therapy within 24 hours

  2. Vomiting

    Time frame: 24 hours

    Vomiting starting or progressing in the first 24 hours of therapy

  3. ORS Intake in ml

    Time frame: 24 hours

    ORS intake in ml (in the first 24 hours, and total)

  4. Weight Gain in Gram

    Time frame: 24 hours

    Weight gain in gram (in the first 24 hours, and total)

  5. Duration of Diarrhea (Hrs)

    Time frame: 7days

    Time of diarrhea in hours

  6. Return Visit to the Emergency Department

    Time frame: 1 week

    Return visit to the emergency department within a week

  7. Hospitalization

    Time frame: 1 week

    need for hospitalization within a week

  8. Adverse Events

    Time frame: 24 hours

    any adverse event, providing a description if related or not related to study intervention

  9. ORS Intake at 4 h

    Time frame: 4 hrs

    % of prescribed ORS that was consumed during first 4 hours

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis: Randomized, Double-Blind Controlled Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 8, 2011
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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