An observational study in Fructose Intolerance, sponsored by Sciotec Diagnostic Technologies GmbH. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Sciotec Diagnostic Technologies GmbH · Observational
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.
Sciotec Diagnostic Technologies GmbH is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Test persons are recruited from the patient pool of the Clinical Department of Gastroenterology and Hepatology of the Medical University Clinic Graz. Fructose intolerance has been detected in these patients by means of aCPQ since March 2017. In addition, those affected will be approached through advertising measures and an aCPQ test for fructose intolerance determination will be carried out as part of the study. A detailed medical history will also be taken to check eligibility for participation in the study.
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Exclusion Criteria:
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.
Also known as: Fructease
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.
Time frame: 28 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2023; primary completion for Jun 2024, 8 months later.
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This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Fructose Intolerance
Sciotec Diagnostic Technologies GmbH