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®

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06044389
• Other study ID #: BTS1295/18
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Sciotec Diagnostic Technologies GmbH
• Contact: Florian Forster, PhD
• Phone: +436766744765
• Email: f.forster[@]sciotec.at
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Fructose Intolerance

Intervention

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.

Locations

Country	Name	City	State
Austria	Sciotec Diagnostic Technologies GmbH	Tulln	Niederösterreich

Sponsors (1)

Lead Sponsor	Collaborator
Sciotec Diagnostic Technologies GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of FRuctosin	Adverse events are recorded by the study participants by means of a diary and asked about by the study investigators at the end of the study (final visit).; At the final visit, the subjects are asked about any changes in their health status. Any symptoms that occur that go beyond the symptoms of fructose intolerance are documented as adverse events (AE). All distinguishing features between adverse and serious adverse events, defined in accordance with the ICH/GCP guidelines, are queried and documented in the electronic case report form.; AE are documented in source documents and include description, time period, treatment, intensity (1 mild, 2 moderate, 3 severe) and outcome (1 recovered, 2 recovered with limitation, 3 not yet recovered, 4 unknown), as well as severity (yes/no) and possible association (0 no association, 1 unlikely, 2 possible, 3 probable, 4 certain). The assessment of the association of AEs with the study medication is made by the investigator.	28 days