Effect of Probiotics on Stress in Young Adults

Study Overview
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Brief Summary
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The study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).

Detailed Description
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The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST), comparing probiotics with placebo. The participants will receive either one of the two test products or placebo daily for a period of eight weeks. At Visit 1, the participants will be dispensed with study product and complete the Cohen's Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected for biomarker analysis. At Visit 2, participants will undergo a TSST and will complete the PSS and STAI questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for biomarker analysis.

Official Title
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Effect of Probiotics on Stress in Young Adults: a Randomized, Double-blind, Placebo-controlled Study

Conditions
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Stress

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give informed e-consent Be between 18 and 45 years old, inclusive In general good health, as determined by the investigator Have a BMI of ≥18.5 and <30.0 kg/m2 Willing to consume the study product daily for the duration of the study and comply with the study procedures Have moderate stress, as measured on the Cohen's Perceived Stress Scale, with a score between 14 and 26 (inclusive) Be able to communicate well with the Investigator, to understand and comply with the study requirements and be judged suitable for the study in the opinion of the investigator Exclusion Criteria: Scores ≥10 on General Anxiety Disorder 7 item (GAD-7) and Patient Health Questionnaire 9 item (PHQ-9) Have a history of in-person public speaking or presenting to large groups regularly (≥2 times/year) in the past 12 months Have a known major stressful life event occurring (current or upcoming) during the study Participants who have a significant illness or condition which may, in the opinion of the investigator impact their ability to participate in the study or impact the study outcomes (e.g. any chronic disease, including hypertension, type 1 or 2 diabetes, cardiovascular diseases, gastrointestinal disorders, celiac disease, and IBD) Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function Use of oral or systemic (topical allowed) immunosuppressant drugs, antibiotics, steroids, etc. within the one month before screening Consumption of probiotic supplements that contain live bacteria in the 4 weeks before the screening Regular use of anti-inflammatory drugs such as aspirin or ibuprofen (>200mg/24 hours) Food allergy or hypersensitivity to any component of the product Heavy alcohol use or recent history (within one year) of illicit drug use Participants who work night shifts Participation in other clinical trials or studies in the last month Desire and/or plans on changing current diet and/or exercise regime during the participation of this study Participants who are pregnant or wish to become pregnant during the study Participants who are lactating and/or currently breastfeeding Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics combined strains<br>Probiotics combined strains administered as oral capsules once daily | Dietary Supplement: Probiotics<br>* Oral capsules<br>|
| Experimental: Probiotics single strain<br>Probiotics single strain administered as oral capsules once daily | Dietary Supplement: Probiotics<br>* Oral capsules<br>|
| Placebo Comparator: Placebo<br>Placebo capsule administered orally once daily | Dietary Supplement: Placebo<br>* Oral capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress | Change in Perceived Stress Visual Analog Scale (VAS) in response to TSST | Before, during, and after TSST at visit 2 (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI score | Change in State-Trait Anxiety Index (STAI) in response to TSST. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety. | Before and after TSST at visit 2 (week 8) | 
| PSS score | Change in Cohen's Perceived Stress Scale (PSS) from baseline to week 8. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | baseline and week 8 | 
| STAI score | Change in State-Trait Anxiety Index (STAI) from baseline to week 8. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety. | baseline and week 8 | 
| Anxiety | Change in Anxiety Visual Analog Scale (VAS) in response to TSST | Before, during, and after TSST at visit 2 (week 8) | 
| Emotional insecurity | Change in Emotional Insecurity Visual Analog Scale (VAS) in response to TSST | Before, during, and after TSST at visit 2 (week 8) | 
| Exhaustion | Change in Exhaustion Visual Analog Scale (VAS) in response to TSST | Before, during, and after TSST at visit 2 (week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Mental Health