Effects of Probiotic Supplementation on Stress and Anxiety in Students (NCT07470645) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Probiotic Supplementation on Stress and Anxiety in Students
Poland200 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in perceived stress score
Timeframe: Change in total perceived stress score from baseline to week 5 and to week 8 (±3 days) compared to placebo