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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021586

Enrollment

Registered

2020-04-30

Start date

2020-05-20

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E74.3

Interventions

Group 1: Fructaid (glucose isomerase), 2-4 capsules/day p.o., single dose

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria: Congenital (hereditary) fructose-intolerance

Design outcomes

Primary

Measure	Time frame
Hydrogen concentration in exhaled air, calculation of the AUC (area under the curve) after fructose intake	—

Secondary

Measure	Time frame
Max increase of hydrogen (Cmax) in exhaled air after fructose intake; Assessment of overall complaints after fructose intake; Assessment of single symptoms after fructose intake	—

Countries

Germany

Contacts

Public ContactYvonne Moedinger

BioTeSys GmbH

studienzentrum@biotesys.de+49-711-3513836

Outcome results

None listed

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