Fructose IntoleranceNCT06044389
Observational Study on the Safety and Efficacy of the Medical Product Fructosin.
An observational study of Fructose Intolerance, run by Sciotec Diagnostic Technologies GmbH at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fructose Intolerance
- What is being tested?
- Fructosin
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2023to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Sciotec Diagnostic Technologies GmbH
Tulln, Lower Austria, 3430
Florian Forster, PhD, +436766744765, f.forster@sciotec.at
Heinz Hammer, MD
About this study
Official title: Anwendungsbeobachtung Zur Sicherheit Und Wirkung Des Medizinproduktes Fructosin®
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
- Being tested
- Fructosin
- Medical subject headings
- Fructose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructosinDevice
Also called Fructease
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.
| Study group | Role | What they receive |
|---|---|---|
| People suffering from fructose intolerance | Not described Receives: Device: Fructosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fructose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sciotec Diagnostic Technologies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044389
- Sponsor's protocol ID
- BTS1295/18
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anwendungsbeobachtung Zur Sicherheit Und Wirkung Des Medizinproduktes Fructosin®
- ClinicalTrials.gov ID
- NCT06044389
- Acronym / sponsor ID
- BTS1295/18
- Conditions
- Fructose Intolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sciotec Diagnostic Technologies GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People suffering from fructose intolerance | – | Device: Fructosin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FructosinAlso: FructeaseFructosin® 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. | Device | People suffering from fructose intolerance |
Primary outcome
Safety of FRuctosin
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fructose Intolerance, run by Sciotec Diagnostic Technologies GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Forster, PhD (+436766744765, f.forster@sciotec.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of FRuctosin (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.