NCT06044389

Observational Study on the Safety and Efficacy of the Medical Product Fructosin.

Anwendungsbeobachtung Zur Sicherheit Und Wirkung Des Medizinproduktes Fructosin®

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Sciotec Diagnostic Technologies GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 fructose intolerance will be investigated. The study participants will be informed about the nature and scope of the study during a preliminary examination (screening) and a declaration of consent will be obtained. In addition, it is determined whether fructose intolerance is present. This is determined by means of the aCPQ test. Subsequently, the patients fill out symptom questionnaires (IBS-SSS, IBS-QoL, 1-week symptom questionnaire). After the eligibility check, a 14-day phase of monitoring and documentation of symptoms and complaints without taking Fructosin® (observation phase) takes place. At visit 1, the patients receive the Fructosin® capsules, which they take as needed, but no more than 2 x 3 times a day with fruit meals. The intake phase runs over a period of 28 days (4 weeks) during which the study participants observe and evaluate gastrointestinal symptoms with the help of the 1-weekly symptom questionnaire. In addition, the daily fructose consumption (fruit, fruit juices, smoothies) and the amount of Fructosin® capsules taken are documented in a diary.

Conditions

• Fructose Intolerance

Interventions

Type	Name	Description
DEVICE	Fructosin	Fructosin® is a CE marked medical device. The capsules with 30.23 mg xylose isomerase are taken as recommended. This means that, depending on the total intake, 1-2 capsules are to be taken with water 15 minutes before meals containing fructose, a maximum of 3 times a day. Use as needed during the 4-week intake phase.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Austria