Status:
UNKNOWN
Observational Study on the Safety and Efficacy of the Medical Product Fructosin.
Lead Sponsor:
Sciotec Diagnostic Technologies GmbH
Conditions:
Fructose Intolerance
Eligibility:
All Genders
18-80 years
Brief Summary
Fructosin® is a medical device for use in fructose intolerance. In this uncontrolled posdt market clinical follow up (PMCF) study, the safety and efficacy of oral supplementation of Fructosin® in fruc...
Eligibility Criteria
Inclusion
- Positive result of the aCPQ test after 25 g fructose ingestion.
- Age: 18 - 80 years; 18 years of age must be completed and the legal capacity must be given.
Exclusion
- Pregnancy and breastfeeding
- Congenital (hereditary) fructose intolerance
- Participation in a clinical trial in the past 4 weeks
- At the investigator's discretion: physical findings or previous illness for which a recommendation to take fructosin is not indicated or for which an assessment of the questionnaire by the patient is not possible.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06044389
Start Date
October 1 2023
End Date
August 1 2024
Last Update
September 21 2023
Active Locations (1)
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1
Sciotec Diagnostic Technologies GmbH
Tulln, Lower Austria, Austria, 3430