NCT04494178TerminatedNot Applicable
A Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate the Effect of G-PUR® on Dietary Fumonisin Bioavailability
Glock Health, Science and Research GmbH1 site in 1 country7 target enrollmentStarted: August 18, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female subjects
- •Age 18-55 years
- •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
Exclusion Criteria
- •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
- •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
Arms & Interventions
2.0g G-PUR® oral - Placebo
Experimental
Intervention: Placebo (Other)
2.0g G-PUR® oral - Placebo
Experimental
Intervention: 2.0g G-PUR® (Device)
Placebo - 2.0g G-PUR® oral
Experimental
Intervention: 2.0g G-PUR® (Device)
Placebo - 2.0g G-PUR® oral
Experimental
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2
Time Frame: 24 hours
Secondary Outcomes
- Incidence of (serious) adverse device effects(19 days)
- Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)(24 hours)
Investigators
Study Sites (1)
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