NCT05840978

Effect of Probiotics on Stress in Young Adults

Effect of Probiotics on Stress in Young Adults: a Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Chr Hansen · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).

Detailed description

The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST), comparing probiotics with placebo. The participants will receive either one of the two test products or placebo daily for a period of eight weeks. At Visit 1, the participants will be dispensed with study product and complete the Cohen's Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected for biomarker analysis. At Visit 2, participants will undergo a TSST and will complete the PSS and STAI questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for biomarker analysis.

Conditions

• Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Oral capsules
DIETARY_SUPPLEMENT	Placebo	Oral capsules

Timeline

• Start date: 2023-04-05
• Primary completion: 2023-12-11
• Completion: 2023-12-11
• First posted: 2023-05-03
• Last updated: 2023-12-15

Locations

1 site across 1 country: Ireland