Post-Market Clinical Follow-up study (PMCF) for confirmation of the performance and safety of Fructaid®

Not Applicable

• Conditions: E74.3; Other disorders of intestinal carbohydrate absorption

• Registration Number: DRKS00021586
• Lead Sponsor: Vitacare GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-30
• Study Completion: 2020-12-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Confirmed fructose-malabsorption after administration of 25 g of fructose via H2-breath test (increase of H2 > 20 ppm above baseline)

Exclusion Criteria

Congenital (hereditary) fructose-intolerance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hydrogen concentration in exhaled air, calculation of the AUC (area under the curve) after fructose intake

Secondary Outcome Measures

Name	Time	Method
Max increase of hydrogen (Cmax) in exhaled air after fructose intake; <br>Assessment of overall complaints after fructose intake; <br>Assessment of single symptoms after fructose intake