NCT04125810

A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress

A Randomized, Triple-blind, Placebo-controlled, Parallel-groups Clinical Trial to Assess the Safety and Efficacy of Lactobacillus Paracasei (Lpc-37) to Modulate Psychological Stress

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.

Detailed description

The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo. The target group of the proposed study will consist of stress vulnerable / sensitive, healthy male and female adult participants currently enrolled in medical, dental or health science university course that are experiencing psychological stress induced by preparation for university/institute of technology semester examination (s).

Conditions

• Stress, Psychological
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Probiotic	Probiotic
OTHER	Placebo	Placebo

Timeline

• Start date: 2019-09-02
• Primary completion: 2020-02-07
• Completion: 2020-02-07
• First posted: 2019-10-14
• Last updated: 2020-03-25

Locations

7 sites across 2 countries: Ireland, United Kingdom