About this trial
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.
Eligibility criteria
Qualifiers
Male or female students aged 18-40 years
At least moderate stress (DASS-21 Stress score ≥10)
Mild anxiety (DASS-21 Anxiety score 6-13)
No clinical depression (DASS-21 Depression score ≤9)
Disqualifiers
Irritable bowel syndrome (Rome IV criteria) or any chronic intestinal disease (including celiac disease)
Known food allergies, immunodeficiency disorders, or immunosuppressive treatment
Antibiotic use within 4 weeks prior to screening
Any psychiatric illness within the past 5 years
Trial design
Treatments tested in this trial
- Probiotics
- Placebo
Treatment groups
Sponsors and collaborators
Nordic Biotic Sp. z o.o.
Lead sponsor
Wörwag Pharma GmbH & Co. KG
Collaborator