Effects of Probiotic Supplementation on Stress and Anxiety in Students

NCT07470645 | Not Yet Recruiting

• 1 other identifier: CT/NB/180/2025/PR-MS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probiotics; Stress; Anxiety; Gut-brain axis

Outcome Measures

Primary Outcomes (1)

• Change in perceived stress score

  Perceived stress will be assessed using the 10-Item Perceived Stress Scale (PSS-10), a validated questionnaire measuring the degree to which situations in one's life are appraised as stressful. The total score ranges from 0 to 40, with higher scores indicating higher perceived stress levels (worse outcome). Changes in the total score from baseline will be analyzed to evaluate the effect of probiotic supplementation.

  Change in total perceived stress score from baseline to week 5 and to week 8 (±3 days) compared to placebo

Secondary Outcomes (6)

• Change in stress, anxiety and depression scores

  Change in DASS-21 Stress, Anxiety, and Depression subscale scores from baseline to week 5 and week 8 (±3 days) compared to placebo.

• Change in sleep quality score

  Change in Pittsburgh Sleep Quality Index (PSQI) global score from baseline to week 5 and week 8 (±3 days) compared to placebo.

• Change in sense of coherence score

  Change in Sense of Coherence Scale - 29 Items (SOC-29) total score from baseline to week 5 and week 8 (±3 days) compared to placebo.

• Change in state anxiety score

  Change in State-Trait Anxiety Inventory - State version (STAI-S) total score from baseline to week 8 compared to placebo.

• Change in severity of gastro-intestinal symptoms

  Change from baseline in gastro-intestinal severity score at Week 5 and Week 8 compared to placebo

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Two capsules containing Lactobacillus plantarum LP140 and Bifidobacterium breve BB010 will be administered orally once daily (total daily dose of 1 × 10¹⁰ colony-forming units) for 8 weeks.

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Maltodextrin will be used as a placebo. The placebo capsules will be identical in appearance to the probiotic capsules and will be administered orally once daily (two capsules) for 8 weeks.

Other: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Lactobacillus plantarum LP140 and Bifidobacterium breve BB010

Probiotic

Placebo OTHER

Maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Willingness to maintain usual diet, physical activity, and intake of caffeinated beverages during the study
• Written informed consent

You may not qualify if:

• 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
• Any malignant disease or autoimmune or allergic diseases (e.g., atopic dermatitis, asthma)
• Use of systemic psychotropic medications or steroids; use of topical corticosteroid creams within 4 weeks prior to screening
• Pregnancy, breastfeeding, or plans to become pregnant during the study
• Probiotic or prebiotic consumption or planned dietary changes within 4 weeks prior to screening
• Heavy caffeine consumption (\>4 cups of 300 mL coffee per day)
• Drug or alcohol addiction or regular use of recreational drugs
• Smoking more than 10 cigarettes per day

Sponsors & Collaborators

• Nordic Biotic Sp. z o.o.: lead
• Wörwag Pharma GmbH & Co. KG: collaborator

Study Sites (1)

University of Lublin, Faculty of Health Sciences

Lublin, Poland

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Emilia Majsiak, Prof. PhD

  Medical University of Lublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilia Majsiak, Professor of University, PhD

CONTACT

+48667633263; Emilia.Majsiak@umlub.edu.pl

Bożena Cukrowska, Prof., MD, PhD

CONTACT

609447892; bc@nordicbiotic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)