Effects of Probiotic Supplementation on Stress and Anxiety in Students

Study acronym: PROfoS
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Study completion pushed from Aug 15, 2026 to Oct 15, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Site details revised
    • Collaborators: details revised at 1 of 1 entry
  2. Notable Primary endpoint revisedv2 Show 4 more changesShow less
    • Secondary endpoints revised (6)
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 2 words
    • Study title expanded, about 1 word
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07470645
Lead Sponsor Nordic Biotic Sp. z o.o.
Collaborators: Wörwag Pharma GmbH & Co. KG
Conditions
(from sponsor)
Stress, Anxiety, Sleep, Gastro-intestinal Symptoms in Healthy Subjects
Related terms Anxiety Disorders
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov