Fructose Intolerance
Conditions
Interventions
Product Name: Fruktose capsules
Pharmaceutical Form: Capsule*
CAS Number: 9023-82-9
Current Sponsor code: Fructose capsules
Other descriptive name: Capsules containing the enzyme Xylose Isomerase
Con
Sponsors
SCIOTEC DIAGNOSTIC TECHNOLOGIES GMBH
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: pregnancy, diabetes melitus I,II; celiac disease; recent op; recent endoscopy; recent antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria
Outcome results
None listed