Stress & Anxiety Dampening Effects of a Probiotic Supplement Compared to Placebo in Healthy Subjects

Inclusion Criteria

• Voluntary, written, informed consent to participate in the study
• Male or female aged between 18-45 years (inclusive)
• Body mass index (BMI) between 18.5 - 29.9 kg/m2
• Medical examination at baseline indicates they are healthy in the opinion of the investigator
• Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
• Agreement to comply with the protocol and study restrictions
• Available for all study visits
• Females of child-bearing potential required to provide a negative urine pregnancy test and to use contraceptives
• Easy access to internet

Exclusion Criteria

• Self-reported diagnosis of one or more Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV axis 1 disorder(s), including but not limited to current major depression, anxiety disorder, bipolar spectrum disorder or schizophrenia
• Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic, neurodevelopmental or any condition which contraindicates, in the Investigator's judgement, entry to the study
• Currently taking (from day of screening onwards) or have previously taken (last 4 weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
• Currently taking (from day of screening onwards) medication or dietary supplements that the Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results (e.g. melatonin, omega-3 dietary supplements, non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter (OTC) sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, proton pump inhibitors, anti-histamines, pseudoephedrine, cortisone, beta-blockers)
• Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period
• Daily consumption of concentrated sources of probiotics and/or prebiotics within 2 weeks of screening and throughout the intervention period other than the provided study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders)
• Pregnant or lactating female, or pregnancy planned during intervention period
• Not fluent in German
• Have self-reported dyslexia
• History of alcohol, drug, or medication abuse
• Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to screening and during the intervention period
• Contraindication to any substance in the investigational product
• Hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
• Known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months)
• Subjects having previously participated in the TSST
• Smoking > 5 cigarettes/day
• Employee of the sponsor or contract research organization (CRO)
• Participation in another study with any investigational product within 60 days of screening and during the intervention period
• Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
• Participant under administrative or legal supervision