Effects of Probiotic Supplementation on Stress and Anxiety in Students

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorNordic Biotic Sp. z o.o.

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

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nordic Biotic Sp. z o.o.

Lead sponsor

Wörwag Pharma GmbH & Co. KG

Collaborator