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NOT YET RECRUITING
NCT07470645
NA

Effects of Probiotic Supplementation on Stress and Anxiety in Students

Sponsor: Nordic Biotic Sp. z o.o.

View on ClinicalTrials.gov

Summary

This randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of an 8-week probiotic supplementation (Lactobacillus plantarum LP140 and Bifidobacterium breve BB010 in total daily dose 1 × 10¹⁰ CFU or matching placebo) in reducing perceived stress and anxiety, and improvement related psychological parameters in healthy university students during the examination period. The primary outcome is the change in Perceived Stress Scale (PSS-10) score at week 5 and week 8 of interevention compared to placebo. The secondary outcomes are the changes in DASS-21 subscales (Stress, Anxiety, Depression), State-Trait Anxiety Inventory - State version scale (STAI-S), Sense of Coherence Scale (SOC-29), Pittsburgh Sleep Quality Index (PSQI), self-reported gastrointestinal symptoms (Likert scale) and incidence of adverse events during the 8-week lasting interventional study.

Official title: The Efficacy of Probiotic Supplementation in Reducing Stress and Anxiety: A Randomized, Placebo-Controlled Study in Healthy Students During the Examination Period

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-04-20

Completion Date

2026-08-15

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Probiotics

Lactobacillus plantarum LP140 and Bifidobacterium breve BB010

OTHER

Placebo

Maltodextrin

Locations (1)

University of Lublin, Faculty of Health Sciences

Lublin, Poland