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G-PUR® for Reduced Dietary Fumonisin Bioavailability

NCT ID: NCT04494178

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-18

Study Completion Date

2020-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Reduction of Dietary Fumonisin Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2.0g G-PUR® oral - Placebo

Group Type EXPERIMENTAL

2.0g G-PUR®

Intervention Type DEVICE

Oral administration (Intervention period I)

Placebo

Intervention Type OTHER

Intervention period II

Placebo - 2.0g G-PUR® oral

Group Type EXPERIMENTAL

2.0g G-PUR®

Intervention Type DEVICE

Oral administration (Intervention period II)

Placebo

Intervention Type OTHER

Intervention period I

Interventions

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2.0g G-PUR®

Oral administration (Intervention period I)

Intervention Type DEVICE

2.0g G-PUR®

Oral administration (Intervention period II)

Intervention Type DEVICE

Placebo

Intervention period I

Intervention Type OTHER

Placebo

Intervention period II

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glock Health, Science and Research GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Wolzt, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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G-Fum_01

Identifier Type: -

Identifier Source: org_study_id