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

NCT06044389 | Unknown

• 1 other identifier: BTS1295/18
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fructose Intolerance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

People suffering from fructose intolerance

Device: Fructosin

Interventions

Fructosin DEVICE

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

People suffering from fructose intolerance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sciotec Diagnostic Technologies GmbH: lead

Study Sites (1)

Sciotec Diagnostic Technologies GmbH

Tulln, Lower Austria, 3430, Austria

Location

MeSH Terms

Conditions

Fructose Intolerance

Condition Hierarchy (Ancestors)

Fructose Metabolism, Inborn Errors; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Florian Forster, PhD

CONTACT

+436766744765; f.forster@sciotec.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)