Gastric flu study

Acute gastroenteritis in paediatrics : Comparison of two oral rehydration preparations - A randomized pilot study - OralRehyd

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002004-92-AT

Enrollment

Registered

2015-06-10

Start date

2015-09-09

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute gastroenteritis MedDRA version: 20.0 Level: LLT Classification code 10017784 Term: Gastric flu System Organ Class: 100000004862

Interventions

Trade Name: Normolyt Pharmaceutical Form: Powder for oral solution INN or Proposed INN: glucose CAS Number: 50-99-7 Other descriptive name: GLUCOSE, ANHYDROUS Concentration unit: g gram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Hospitalisation due to acute gastroenteritis • Written informed consent of the parents of the participating child and the child's informed consent • Age: 1-13 years • necessity of receiving an oral rehydration preparation Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Parenteral rehydration • A history of hypersensitivity to any of the active substances or ingredients used • Diabetes mellitus • kidney diseases • reduction in blood acidity • persistent vomiting • disturbances of consciousness and unconsciousness • Metabolic alkalosis • anuria • monosaccharide malabsorption • Shock •Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this clinical trial is to investigate whether Lytomed® finds greater acceptance among children of 1-13 years compared to Normolyt®.;Secondary Objective: Alterations of base excess Change of the duration of the hospitalisation Alterations of body weight Change of compliance;Primary end point(s): Acceptance of the oral Rehydration solution. ;Timepoint(s) of evaluation of this end point: 0-maximum 72 hours after first admission	—

Measure

Time frame

Main Objective: The primary objective of this clinical trial is to investigate whether Lytomed® finds greater acceptance among children of 1-13 years compared to Normolyt®.;Secondary Objective: Alterations of base excess Change of the duration of the hospitalisation Alterations of body weight Change of compliance;Primary end point(s): Acceptance of the oral Rehydration solution. ;Timepoint(s) of evaluation of this end point: 0-maximum 72 hours after first admission

—

Secondary

Measure	Time frame
Secondary end point(s): base excess duration of the hospitalisation body weight compliance;Timepoint(s) of evaluation of this end point: 0-maximum 72 hours after first admission	—

Countries

Austria

Contacts

Public ContactDepartment of general paediatrics

Medical University of Graz

harald.haidl@medunigraz.at+433163853008

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026