Health TrialsbyHealthPanel

Effects of Probiotic Supplementation on Stress and Anxiety in Students

ConditionsStressAnxietySleepGastro-intestinal Symptoms in Healthy Subjects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorNordic Biotic Sp. z o.o.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotics

    Dietary supplement

    Lactobacillus plantarum LP140 and Bifidobacterium breve BB010

  • Placebo

    Other intervention

    Maltodextrin

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ProbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

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.
2

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.

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

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.

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.
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nordic Biotic Sp. z o.o.

Lead sponsor

Wörwag Pharma GmbH & Co. KG

Collaborator

Source ClinicalTrials.gov
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