PRObiotic and Stress-related PERmeability

NCT03408691 | Completed DMC

• 1 other identifier: S60969
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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 defending a bachelor's or master's thesis in front of a jury at the University of Leuven (Belgium).

Conditions

Permeability; Increased

Keywords

probiotic; permeability; stress

Outcome Measures

Primary Outcomes (1)

• Lactulose-Mannitol Ratio (LMR) during the stress condition vs. baseline

  LMR or in vivo small intestinal permeability during stress condition vs. baseline in the Test product with probiotic compared to the acidified milk Control arm

  oral administration of Test or Control product for 4 weeks before stress condition

Secondary Outcomes (4)

• LMR during administration of Test or Control product vs. baseline

  oral administration of Test or Control product for 2 weeks

• LMR after indomethacin vs. baseline

  oral administration of Test or Control product for 6 weeks before indomethacin

• Salivary cortisol during the stress condition vs. baseline

  oral administration of Test or Control product for 4 weeks before stress condition

• Subjective anxiety levels (STAI state) during the stress condition vs. baseline

  oral administration of Test or Control product for 4 weeks before stress condition

Study Arms (3)

Test product

ACTIVE COMPARATOR

Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks

Dietary Supplement: Fresh fermented dairy drink containing probiotic strain

Control product

PLACEBO COMPARATOR

Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks

Other: Acidified dairy drink without ferment

No product

NO INTERVENTION

no product

Interventions

Fresh fermented dairy drink containing probiotic strain DIETARY_SUPPLEMENT

Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks.

Test product

Acidified dairy drink without ferment OTHER

Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks.

Control product

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Belgie, 3000, Belgium

Location

Related Publications (2)

• Vanuytsel T, van Wanrooy S, Vanheel H, Vanormelingen C, Verschueren S, Houben E, Salim Rasoel S, Tomicronth J, Holvoet L, Farre R, Van Oudenhove L, Boeckxstaens G, Verbeke K, Tack J. Psychological stress and corticotropin-releasing hormone increase intestinal permeability in humans by a mast cell-dependent mechanism. Gut. 2014 Aug;63(8):1293-9. doi: 10.1136/gutjnl-2013-305690. Epub 2013 Oct 23.

  PMID: 24153250 BACKGROUND

• Wauters L, Van Oudenhove L, Accarie A, Geboers K, Geysen H, Toth J, Luypaerts A, Verbeke K, Smokvina T, Raes J, Tack J, Vanuytsel T. Lactobacillus rhamnosus CNCM I-3690 decreases subjective academic stress in healthy adults: a randomized placebo-controlled trial. Gut Microbes. 2022 Jan-Dec;14(1):2031695. doi: 10.1080/19490976.2022.2031695.

  PMID: 35130109 DERIVED

Study Officials

• Tim Vanuytsel, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind only in Test and Control arm open label in arm without intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-site exploratory randomized, controlled interventional trial with a parallel group design: double blind with Test and Control arm + open label arm without intervention.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: January 23, 2018
• Primary Completion: March 22, 2019
• Study Completion: March 31, 2019
• Last Updated: June 4, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)