Efficacy of Fructose metabolizing enzymatic product Fructosin(R) with Fructose malabsorption ( Wirkamkeit des Fruktose-abbauenden Enzympräparates Fructosin® bei Fruktose-Malabsorption) - Fruktosin Study

• Conditions: Fructose Intolerance; Incapability to digest fructose contained in food

• Registration Number: EUCTR2008-005861-80-AT
• Lead Sponsor: SCIOTEC DIAGNOSTIC TECHNOLOGIES GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

clinically diagnosed fructose malabsorption;
Age: 18-80;
both sexes
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

pregnancy, diabetes melitus I,II;
celiac disease;
recent op;
recent endoscopy;
recent antibiotics

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of used active ingredient to decrease symptoms of Fructose Intoplerance after the intake of fructose containing food by a preselected group of test persons. Documentation of the absence of side effects of the test substance.;Secondary Objective: Claim proof according to EU claims regulation.;Primary end point(s): significant reduction of hydrogen in breathing air after fructose intake with active substance