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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).
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 acidified milk Control) plus an extra open label arm without intervention in a 2:2:1 ratio. The goal of the open-label arm is to confirm our previous data on the effect of stress on small intestinal permeability (see reference), without powering the study to detect a significant difference within this open-label arm. The participants and the investigators are blinded to the allocation to the probiotic vs. acidified milk control arm. However, there is no blinding in the arm without intervention.
In vivo intestinal permeability and salivary markers of psychological stress and activation of the autonomous nervous system will be measured and questionnaires will be completed at 4 different test days: baseline (V2), two weeks after randomization (V3), during an oral defense of a master's or bachelor's thesis (V4) and finally after pretreatment with Indomethacin (V5).
The 5 study visits are organized around the thesis defence (D0):
V1 (screening + inclusion) takes place within 2 to 3 weeks prior to the randomization.
V2 (baseline + randomization) will take place between D-35 to D-27. V3 (randomization + 2 weeks) will take place at D-14 +/-1day. V4 (thesis defense) is D0 and organized by the University. V5 (Indomethacin) will take place at D+14 +/-1day.
For subjects in the intervention arm (Test product with probiotic and acidified milk Control), products will be supplied (for 1 week). In addition, alternate product supply will take place at D-21, D-7 and D+7 (each one +/-1day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Active Comparator | Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks |
|
| Control product | Placebo Comparator | Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks |
|
| No product | No Intervention | no product |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| LMR during administration of Test or Control product vs. baseline | LMR or in vivo small intestinal permeability during administration vs. baseline within each intervention arm and between groups. | oral administration of Test or Control product for 2 weeks |
| LMR after indomethacin vs. baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Vanuytsel, MD PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Leuven | Belgie | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24153250 | Background | 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. | |
| 35130109 |
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Single-site exploratory randomized, controlled interventional trial with a parallel group design: double blind with Test and Control arm + open label arm without intervention.
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double blind only in Test and Control arm open label in arm without intervention
| Acidified dairy drink without ferment | Other | Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks. |
|
LMR or in vivo small intestinal permeability after indomethacin vs. baseline within each intervention arm and between groups |
| oral administration of Test or Control product for 6 weeks before indomethacin |
| Salivary cortisol during the stress condition vs. baseline | Salivary cortisol during the stress condition vs. baseline within each intervention arm and between groups | oral administration of Test or Control product for 4 weeks before stress condition |
| Subjective anxiety levels (STAI state) during the stress condition vs. baseline | Subjective anxiety levels (STAI state) during the stress condition vs. baseline within each intervention arm and between groups | oral administration of Test or Control product for 4 weeks before stress condition |
| Derived |
| 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. |