Status:
COMPLETED
PRObiotic and Stress-related PERmeability
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Permeability; Increased
Eligibility:
All Genders
20-30 years
Phase:
NA
Brief Summary
This is a single-site exploratory study aiming to demonstrate the effect of a fresh fermented dairy drink containing a probiotic strain on stress-related intestinal hyperpermeability in students defen...
Detailed Description
The study is conceived as a single-site exploratory study with a randomized, controlled, parallel group design. There will be a double blind with 2 intervention arms (Test product with probiotic and a...
Eligibility Criteria
Inclusion
- Student defending a bachelor's or master's thesis in front of a jury
- Age 20 till 30 years (both included), both genders
- Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study
- Subject willing to consume 2 units of investigational product per day during the investigational product consumption period.
- For females: If of child bearing potential, female subjects must be using or complying with methods of contraception
- Subject willing to strictly follow dietary/medication instructions for the entire duration of the study
- Subject must have access to a refrigerator with adequate space to store the investigational products according to the labels' storage recommendations and a freezer for the cooling elements in the transport bag
Exclusion
- Subject with chronic gastrointestinal disorders or symptoms, type 1 or type 2 diabetes mellitus, psychiatric disease including but not limited to depression (screened by PHQ-9) and general anxiety disorder (screened by GAD-7), celiac disease, food allergy or a history of atopic conditions (eczema, allergic asthma, allergic rhinoconjunctivitis) requiring active treatment
- Subject with allergy or intolerance to non-steroidal anti-inflammatory drugs (NSAID)
- Subject with first degree relatives with coeliac disease, inflammatory bowel disease (IBD) or type 1 diabetes
- Subject with known or suspected lactose intolerance or suspected allergy or hypersensitivity to any component of the study product(s) (e.g. milk protein)
- Subject receiving (currently or in the 2 last weeks) systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, NSAIDs and steroids prescribed in chronic inflammatory diseases.
- Active smoker with at least 7 cigarettes per week
- Subject consuming regularly (\>1/week) more than 3 units of alcohol per day.
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT03408691
Start Date
January 23 2018
End Date
March 31 2019
Last Update
June 4 2019
Active Locations (1)
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1
KU Leuven
Leuven, Belgie, Belgium, 3000