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

Fructose Intolerance Clinical Trial

Official title: Anwendungsbeobachtung Zur Sicherheit Und Wirkung Des Medizinproduktes Fructosin®

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Fructose Intolerance

• NCT number: NCT06044389
• Study type: Observational
• Source: Sciotec Diagnostic Technologies GmbH
• Contact: Florian Forster, PhD
• Phone: +436766744765
• Email: f.forster@sciotec.at
• Status: Not yet recruiting
• Start date: October 2023
• Completion date: August 2024