Gastric flu study

Phase 1

• Conditions: acute gastroenteritis; MedDRA version: 20.0Level: LLTClassification code 10017784Term: Gastric fluSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-002004-92-AT
• Lead Sponsor: Medizinische Universität Graz, Klinische Abteilung für allgemeine Pädiatrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-10
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified