StressPROfoSNCT07470645
Effects of Probiotic Supplementation on Stress and Anxiety in Students
A study testing Probiotics in people with Stress and Anxiety, run by Nordic Biotic Sp. z o.o. at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 20 Apr 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
University of Lublin, Faculty of Health Sciences
Lublin
Emilia Majsiak, Prof. PhD, +48 667633263, Emilia.Majsiak@umlub.edu.pl
Emilia Majsiak, Prof., PhD
About this study
Official title: The Efficacy of Probiotic Supplementation in Reducing Stress and Anxiety: A Randomized, Placebo-Controlled Study in Healthy Students During the Examination Period
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.
Read the detailed description
The gut-brain axis enables bidirectional communication between the gastrointestinal tract and the central nervous system. Emerging evidence suggests that selected probiotic strains (psychobiotics) may modulate stress responses and emotional regulation. University examination periods constitute a predictable model of transient psychological stress in otherwise healthy individuals.
This study investigates whether daily supplementation with a probiotic combination of Lactobacillus plantarum LP140 and Bifidobacterium breve BB010 reduces perceived stress and improves related psychological parameters in healthy students exposed to exam-related stress. Two hundred male and female students aged 18-40 years with at least moderate stress and mild anxiety, but without clinical depression, will be enrolled at the Medical University of Lublin, Poland. After providing written informed consent and confirming eligibility criteria, participants will be randomized in a 1:1 ratio to receive either a probiotic formulation containing Lactobacillus plantarum LP140 and Bifidobacterium breve BB010 (total daily dose of 1 × 10¹⁰ colony-forming units) or a matching placebo.
The investigational product and placebo will be identical in appearance and administered orally once daily (two capsules) for 8 weeks. Randomization will be computer-generated, and both participants and investigators will remain blinded to treatment allocation throughout the study. The intervention will begin approximately six weeks before the first scheduled academic examination. Study assessments will be conducted at baseline, at week 5 (approximately one week before the first examination), and at week 8 (±3 days before a subsequent examination). Psychological and functional parameters will be collected using validated self-report instruments administered electronically, with selected assessments performed during on-site visits. Participants will be asked to maintain their usual diet, physical activity, and caffeine intake during the study period. Safety and tolerability will be monitored throughout the intervention, and adverse events will be recorded using an electronic reporting system with daily reminders.
The study is powered to detect clinically meaningful differences between groups in perceived stress levels and will be analyzed using appropriate covariance-based statistical models adjusted for baseline values and relevant covariates. All participant data will be coded to ensure confidentiality and handled in accordance with applicable data protection regulations.
- Conditions
- Stress, Anxiety, Sleep, Gastro-intestinal Symptoms in Healthy Subjects
- Being tested
- Probiotics, Placebo
- Keywords
- Probiotics, Stress, Anxiety, Gut-brain axis
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Lactobacillus plantarum LP140 and Bifidobacterium breve BB010
PlaceboOther
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Stress, anxiety, and depression will be assessed using the Depression Anxiety Stress Scales - 21 Items (DASS-21). The DASS-21 consists of three subscales (Depression, Anxiety, and Stress), each including 7 items. Scores for each subscale range from 0 to 42 after standard score multiplication, with higher scores indicating greater symptom severity (worse outcome). Changes in the Stress, Anxiety, and Depression subscale scores from baseline will be analyzed to evaluate the effect of probiotic supplementation.
Measured: 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
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire measuring sleep quality over the previous month. The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome). Changes in the PSQI global score from baseline will be analyzed to evaluate the effect of probiotic supplementation.
Measured: 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
Sense of coherence will be assessed using the Sense of Coherence Scale - 29 Items (SOC-29), a validated questionnaire measuring psychological resilience and the ability to cope with stress. The total score ranges from 29 to 203, with higher scores indicating a stronger sense of coherence (better outcome). Changes in the SOC-29 total score from baseline will be analyzed to evaluate the effect of probiotic supplementation.
Measured: 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
State anxiety will be assessed using the State-Trait Anxiety Inventory - State version (STAI-S), a validated questionnaire measuring the current level of anxiety. The STAI-S total score ranges from 20 to 80, with higher scores indicating higher levels of anxiety (worse outcome). Changes in the STAI-S total score from baseline will be analyzed to evaluate the effect of probiotic supplementation.
Measured: 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
The severitty of gastro-intestinal symptoms will be assessed with the use of 4-point Likert scale (0 - no symptom, 1 - weak, 2 - moderate, 4 - severe). The following symptoms will be assessed: abdominal pain, flatulence, nausea.
Measured: Change from baseline in gastro-intestinal severity score at Week 5 and Week 8 compared to placebo
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Safety and tolerability will be assessed by monitoring the incidence of adverse events throughout the study. Adverse events will be self-reported by participants using an electronic reporting platform, which provides daily reminders for study product intake and allows participants to record any symptoms or adverse events experienced during the study period.
Measured: From baseline through the 8-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start20 Apr 2026
- Primary completion15 Jul 2026
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordic Biotic Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wörwag Pharma GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Emilia Majsiak, Prof. PhD, Principal investigator, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470645
- Sponsor's protocol ID
- CT/NB/180/2025/PR-MS
- Acronym
- PROfoS
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Probiotic Supplementation in Reducing Stress and Anxiety: A Randomized, Placebo-Controlled Study in Healthy Students During the Examination Period
- ClinicalTrials.gov ID
- NCT07470645
- Acronym / sponsor ID
- PROfoS / CT/NB/180/2025/PR-MS
- Conditions
- Stress, Anxiety, Sleep, Gastro-intestinal Symptoms in Healthy Subjects
- Keywords
- Probiotics, Stress, Anxiety, Gut-brain axis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nordic Biotic Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Wörwag Pharma GmbH & Co. KG
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The gut-brain axis enables bidirectional communication between the gastrointestinal tract and the central nervous system. Emerging evidence suggests that selected probiotic strains (psychobiotics) may modulate stress responses and emotional regulation. University examination periods constitute a predictable model of transient psychological stress in otherwise healthy individuals.
This study investigates whether daily supplementation with a probiotic combination of Lactobacillus plantarum LP140 and Bifidobacterium breve BB010 reduces perceived stress and improves related psychological parameters in healthy students exposed to exam-related stress. Two hundred male and female students aged 18-40 years with at least moderate stress and mild anxiety, but without clinical depression, will be enrolled at the Medical University of Lublin, Poland. After providing written informed consent and confirming eligibility criteria, participants will be randomized in a 1:1 ratio to receive either a probiotic formulation containing Lactobacillus plantarum LP140 and Bifidobacterium breve BB010 (total daily dose of 1 × 10¹⁰ colony-forming units) or a matching placebo.
The investigational product and placebo will be identical in appearance and administered orally once daily (two capsules) for 8 weeks. Randomization will be computer-generated, and both participants and investigators will remain blinded to treatment allocation throughout the study. The intervention will begin approximately six weeks before the first scheduled academic examination. Study assessments will be conducted at baseline, at week 5 (approximately one week before the first examination), and at week 8 (±3 days before a subsequent examination). Psychological and functional parameters will be collected using validated self-report instruments administered electronically, with selected assessments performed during on-site visits. Participants will be asked to maintain their usual diet, physical activity, and caffeine intake during the study period. Safety and tolerability will be monitored throughout the intervention, and adverse events will be recorded using an electronic reporting system with daily reminders.
The study is powered to detect clinically meaningful differences between groups in perceived stress levels and will be analyzed using appropriate covariance-based statistical models adjusted for baseline values and relevant covariates. All participant data will be coded to ensure confidentiality and handled in accordance with applicable data protection regulations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticsTwo 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. |
| Placebo | Placebo comparator | Other: PlaceboMaltodextrin 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsLactobacillus plantarum LP140 and Bifidobacterium breve BB010 | Dietary supplement | Probiotic |
| PlaceboMaltodextrin | Other | Placebo |
Primary outcome
Change in perceived stress score
Time frame: Change in total perceived stress score from baseline to week 5 and to week 8 (±3 days) compared to placebo
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.
6 secondary outcomes
Change in stress, anxiety and depression scores
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline in gastro-intestinal severity score at Week 5 and Week 8 compared to placebo
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Time frame: From baseline through the 8-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilia Majsiak, Prof. PhD principal investigator
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Stress and Anxiety, run by Nordic Biotic Sp. z o.o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilia Majsiak, Professor of University, PhD (+48667633263, Emilia.Majsiak@umlub.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress score (time frame: Change in total perceived stress score from baseline to week 5 and to week 8 (±3 days) compared to placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.