Reduction of Dietary Fumonisin BioavailabilityNCT04494178
G-PUR® for Reduced Dietary Fumonisin Bioavailability
A study testing 2.0g G-PUR® in people with Reduction of Dietary Fumonisin Bioavailability, run by Glock Health, Science and Research GmbH at 1 site in Austria.
Trial summary
This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on bioavailability of dietary fumonisin and to evaluate safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Reduction of Dietary Fumonisin Bioavailability
- What is being tested?
- 2.0g G-PUR®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteAustria
- Study dates
- 18 Aug 2020to 4 Nov 2020
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects
- Age 18-55 years
- BMI 17-27
- Subjects are in good clinical and mental health as established by medical history and physical examination
- Subject understands the scope of the study and agrees to strictly adhere to the study related diet plan
- Written informed consent
Who cannot join
- Pregnancy or breastfeeding.
- Lack of willingness or capacity to co-operate appropriately
- Regular use of medications in the previous 2 months (except oral contraception)
- History of malignancies within the past two years or on current anticancer treatment
- History of gastrointestinal pathology such as clinically relevant gastritis, gastric ulcers, inflammatory bowel disease, chronic constipation
- History of diarrhoea within the past 14 days of screening
Show all 17Show fewer
- History of gastrointestinal surgery with exception of appendectomy
- History of any chronic liver disease
- History of autoimmune disease requiring treatment within the past two months of screening
- Known symptomatic food allergies
- Active infection (including HIV and hepatitis B or C), or abnormalities in laboratory testing, vital signs, or physical examination
- Hypersensitivity to aluminium and/or silicon
- Chronic renal disease requiring dialysis
- Alcohol, cigarette or drug abuse
- Presence of any condition that impacts compliance with the study procedures
- Use of any investigational or non-registered product (drug or device) within 30 days preceding the first study product administration, or planned use during the study period
- Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate the Effect of G-PUR® on Dietary Fumonisin Bioavailability
This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on bioavailability of dietary fumonisin and to evaluate safety and tolerability.
- Being tested
- 2.0g G-PUR®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.0g G-PUR®Device
Oral administration (Intervention period I)
2.0g G-PUR®Device
Oral administration (Intervention period II)
PlaceboOther
Intervention period I
PlaceboOther
Intervention period II
| Study group | Role | What they receive |
|---|---|---|
| 2.0g G-PUR® oral - Placebo | Experimental | Not described Receives: Device: 2.0g G-PUR®; Other: Placebo |
| Placebo - 2.0g G-PUR® oral | Experimental | Not described Receives: Device: 2.0g G-PUR®; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2
Measured: 24 hours
Secondary outcomes (2)
Incidence of (serious) adverse device effects
Measured: 19 days
Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start18 Aug 2020
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Why it stopped: Several analytical laboratories failed to develop and validate a suitable assay of urine fumonisin (the primary endpoint) up to date. Because of missing alternatives for an analytical laboratory the objective of the study cannot be met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Dietary Fumonisin BioavailabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glock Health, Science and Research GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Wolzt, Prof.Dr., Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494178
- Sponsor's protocol ID
- G-Fum_01
- Status last verified
- Nov 2020
- First submitted
- 28 Jul 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate the Effect of G-PUR® on Dietary Fumonisin Bioavailability
- ClinicalTrials.gov ID
- NCT04494178
- Acronym / sponsor ID
- G-Fum_01
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Several analytical laboratories failed to develop and validate a suitable assay of urine fumonisin (the primary endpoint) up to date. Because of missing alternatives for an analytical laboratory the objective of the study cannot be met.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Glock Health, Science and Research GmbHIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 31 Jul 2020 (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.
This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on bioavailability of dietary fumonisin and to evaluate safety and tolerability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.0g G-PUR® oral - Placebo | Experimental | Device: 2.0g G-PUR®, Other: Placebo |
| Placebo - 2.0g G-PUR® oral | Experimental | Device: 2.0g G-PUR®, Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and female subjects
- Age 18-55 years
- BMI 17-27
- Subjects are in good clinical and mental health as established by medical history and physical examination
- Subject understands the scope of the study and agrees to strictly adhere to the study related diet plan
Key exclusion criteria (17 listed)
- Pregnancy or breastfeeding.
- Lack of willingness or capacity to co-operate appropriately
- Regular use of medications in the previous 2 months (except oral contraception)
- History of malignancies within the past two years or on current anticancer treatment
- History of gastrointestinal pathology such as clinically relevant gastritis, gastric ulcers, inflammatory bowel disease, chronic constipation
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 |
|---|---|---|
| 2.0g G-PUR®Oral administration (Intervention period I) | Device | 2.0g G-PUR® oral - Placebo |
| 2.0g G-PUR®Oral administration (Intervention period II) | Device | Placebo - 2.0g G-PUR® oral |
| PlaceboIntervention period I | Other | Placebo - 2.0g G-PUR® oral |
| PlaceboIntervention period II | Other | 2.0g G-PUR® oral - Placebo |
Primary outcome
The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2
Time frame: 24 hours
2 secondary outcomes
Incidence of (serious) adverse device effects
Time frame: 19 days
Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Several analytical laboratories failed to develop and validate a suitable assay of urine fumonisin (the primary endpoint) up to date. Because of missing alternatives for an analytical laboratory the objective of the study cannot be met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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.
Michael Wolzt, Prof.Dr. principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.0g G-PUR® in people with Reduction of Dietary Fumonisin Bioavailability, run by Glock Health, Science and Research 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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 16 Nov 2020. 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?
The study was stopped early (reason given: Several analytical laboratories failed to develop and validate a suitable assay of urine fumonisin (the primary endpoint) up to date. Because of missing alternatives for an analytical laboratory the objective of the study cannot be met.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2 (time frame: 24 hours). 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 16 Nov 2020.