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NCT07470645From ClinicalTrials.govRecruiting

Effects of Probiotic Supplementation on Stress and Anxiety in Students

The Efficacy of Probiotic Supplementation in Reducing Stress and Anxiety: A Randomized, Placebo-Controlled Study in Healthy Students During the Examination Period

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

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Nordic Biotic Sp. z o.o.
Enrolment target
200
Started
20 April 2026
Main results due
15 July 2026
Study sites
1
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 40 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • University of Lublin, Faculty of Health Sciences

    Lublin, Poland

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07470645. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Effects of Probiotic Supplementation on Stress and Anxiety in Students | Trialion