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OpenTrials
Completed

NCT Number: NCT05247879

Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency departments with gastroenteritis.

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Key information

Conditions

Gastroenteritis Acute

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramathibodi Hospital, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1 to 5 years of age, inclusive at randomization
  • Hospitalized with mild to moderate dehydration due to ongoing diarrhea
  • Signed informed consent obtained for child's participation in the study

Exclusion criteria

  • Severe dehydration and/or use of IV fluids for current hospitalization
  • Experiencing bloody diarrhea or diarrhea due to Cholera, Dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use
  • In the opinion of the Investigator, not suitable for treatment with ORS
  • Have any underlying disease or disorder that may, in the opinion of the Investigator, affect the results of the study if they were enrolled (includes, but is not limited to, gastrointestinal disorders such as Crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders)
  • Cause of the dehydration is something other than diarrhea
  • Known to be allergic to any of the components of the Investigational ORS

Treatment and study plan

Glucose containing Oral Rehydration Solution (ORS)

Dietary Supplement

Oral rehydration solution

Sugar free - amino acid and electrolyte ORS

Dietary Supplement

Glucose free oral rehydration solution

Primary outcomes

  1. Clinically assessed adequate rehydration based on clinical judgement of change in or absence of presenting symptoms from baseline (i.e. heart rate, urine output, etc.)

    Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first

    Assess change in clinical hydration status from presenting baseline status

Secondary outcomes

  1. Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)

    Time frame: Baseline

    5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum

  2. Study ORS intake (units)

    Time frame: Every 4 hours up to 24 hours or hospital discharge, whichever occurs first

  3. Use of IV fluids

    Time frame: up to 24 hours or hospital discharge, whichever occurs first

  4. Weight

    Time frame: Every 4 hours up to 24 h or at hospital discharge, whichever occurs first

    kg

  5. Participant comfort questionaire

    Time frame: baseline and 24 hours or hospital discharge, whichever occurs first

  6. Parent satisfaction questionnaire

    Time frame: baseline and 24 hours or hospital discharge, whichever occurs first

  7. Frequency of vomiting

    Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first

  8. Frequency episodes of urination

    Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first

  9. Frequency of liquid/watery stool

    Time frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first

  10. Time to resolution of liquid/water stool

    Time frame: up to 24 hours or hospital discharge, whichever comes first

  11. Stool for bacterial pathogen culture and viral antigens

    Time frame: up to 24 hours or hospital discharge, whichever comes first

  12. Time ready for discharge

    Time frame: At discharge or 48 hours whichever occurs first

  13. Medically confirmed adverse events collected throughout the study period

    Time frame: 0 hours through 7 days post discharge

  14. Record patient use of antibiotics during hospitalization

    Time frame: up to 24 hours or hospital discharge, whichever comes first

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Official study title

Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution in Children Ages 1-5 Years Presenting to Hospital With Mild or Moderate Dehydration Gastroenteritis: Randomized, Open-label, Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2022
Registry last updated
Mar 25, 2024

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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