Effects of Probiotic Supplementation on Stress and Anxiety in Students

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.

NCT Number	NCT07470645
Lead Sponsor	Nordic Biotic Sp. z o.o. Collaborators: Wörwag Pharma GmbH & Co. KG
Conditions	Stress, Anxiety, Sleep, Gastro-intestinal Symptoms in Healthy Subjects
Enrollment	200 participants
Start Date	2026-04-20
Primary Completion	2026-07-15 (estimated)
Study Completion	2026-08-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-17