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G-PUR® for Reduced Dietary Fumonisin Bioavailability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04494178
Recruitment Status : Terminated (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.)
First Posted : July 31, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Glock Health, Science and Research GmbH

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.

Condition or disease Intervention/treatment Phase
Reduction of Dietary Fumonisin Bioavailability Device: 2.0g G-PUR® Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate the Effect of G-PUR® on Dietary Fumonisin Bioavailability
Actual Study Start Date : August 18, 2020
Actual Primary Completion Date : November 4, 2020
Actual Study Completion Date : November 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2.0g G-PUR® oral - Placebo Device: 2.0g G-PUR®
Oral administration (Intervention period I)

Other: Placebo
Intervention period II

Experimental: Placebo - 2.0g G-PUR® oral Device: 2.0g G-PUR®
Oral administration (Intervention period II)

Other: Placebo
Intervention period I




Primary Outcome Measures :
  1. The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2 [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Incidence of (serious) adverse device effects [ Time Frame: 19 days ]
  2. Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2) [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female subjects
  2. Age 18-55 years
  3. BMI 17-27
  4. Subjects are in good clinical and mental health as established by medical history and physical examination
  5. Subject understands the scope of the study and agrees to strictly adhere to the study related diet plan
  6. Written informed consent

Exclusion Criteria:

  1. Pregnancy or breastfeeding.
  2. Lack of willingness or capacity to co-operate appropriately
  3. Regular use of medications in the previous 2 months (except oral contraception)
  4. History of malignancies within the past two years or on current anticancer treatment
  5. History of gastrointestinal pathology such as clinically relevant gastritis, gastric ulcers, inflammatory bowel disease, chronic constipation
  6. History of diarrhoea within the past 14 days of screening
  7. History of gastrointestinal surgery with exception of appendectomy
  8. History of any chronic liver disease
  9. History of autoimmune disease requiring treatment within the past two months of screening
  10. Known symptomatic food allergies
  11. Active infection (including HIV and hepatitis B or C), or abnormalities in laboratory testing, vital signs, or physical examination
  12. Hypersensitivity to aluminium and/or silicon
  13. Chronic renal disease requiring dialysis
  14. Alcohol, cigarette or drug abuse
  15. Presence of any condition that impacts compliance with the study procedures
  16. 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
  17. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04494178


Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
Sponsors and Collaborators
Glock Health, Science and Research GmbH
Investigators
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Principal Investigator: Michael Wolzt, Prof.Dr. Department of Clinical Pharmacology, Medical University of Vienna
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Responsible Party: Glock Health, Science and Research GmbH
ClinicalTrials.gov Identifier: NCT04494178    
Other Study ID Numbers: G-Fum_01
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No