NCT03408691

PRObiotic and Stress-related PERmeability

The Effect of a Probiotic Strain on Stress-related Intestinal Hyperpermeability in Adult Humans.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 20 Years – 30 Years
• Healthy volunteers: Accepted

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).

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 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).

Conditions

• Permeability; Increased

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fresh fermented dairy drink containing probiotic strain	Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks.
OTHER	Acidified dairy drink without ferment	Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks.

Timeline

• Start date: 2018-01-23
• Primary completion: 2019-03-22
• Completion: 2019-03-31
• First posted: 2018-01-24
• Last updated: 2019-06-04

Locations

1 site across 1 country: Belgium