Observational Study on the Safety and Efficacy of the Medical Product Fructosin.
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| People suffering from fructose intolerance
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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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Safety of FRuctosin [28 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Positive result of the aCPQ test after 25 g fructose ingestion.
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Age: 18 - 80 years; 18 years of age must be completed and the legal capacity must be given.
Exclusion Criteria:
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Pregnancy and breastfeeding
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Congenital (hereditary) fructose intolerance
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Participation in a clinical trial in the past 4 weeks
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sciotec Diagnostic Technologies GmbH | Tulln | Niederösterreich | Austria | 3430 |
Sponsors and Collaborators
- Sciotec Diagnostic Technologies GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BTS1295/18