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Effects of Probiotic Supplementation on Stress and Anxiety in Students

NCT07470645 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Stress
  • Anxiety
  • Sleep
  • Gastro-intestinal Symptoms in Healthy Subjects

Interventions

DIETARY_SUPPLEMENT

Probiotics

Lactobacillus plantarum LP140 and Bifidobacterium breve BB010

OTHER

Placebo

Maltodextrin

Sponsors & Collaborators

  • Wörwag Pharma GmbH & Co. KG

    collaborator UNKNOWN

  • Nordic Biotic Sp. z o.o.

    lead INDUSTRY

Principal Investigators

  • Emilia Majsiak, Prof. PhD · Medical University of Lublin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2026-07-15
Completion
2026-08-15

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470645 on ClinicalTrials.gov