Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue

Exclusion Criteria57

• History of dementia, stroke and other neurological conditions.
• Traumatic loss of consciousness in the last 12 months.
• History of epilepsy or Parkinson's disease.
• Formal diagnosis of anxiety, depression or any psychiatric disorder that the Principal
• Investigator believes would interfere with the objectives of the study and requiring
• treatment (prescription of antidepressant, antipsychotic or other long term medication
• and/or referral for long term psychotherapy) in the last 2 years. Brief interventions
• for normal life events such as exam anxiety or bereavement are not an exclusion.
• Have a significant acute or chronic coexisting illness (cardiovascular,
• gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)),
• immunological, metabolic (including diabetes or cardiovascular disease), endocrine or
• bleeding disorders, neurodevelopmental or any condition which contraindicates, in the
• Principal Investigator's judgement, entry to the study.
• Uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood
• pressure >100 mm Hg).
• 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 that the Principal
• Investigator believes would interfere with the objectives of the study, pose a safety
• risk or confound the interpretation of the study results such as:
• high dose anticoagulant medication such as warfarin, heparin, clopidogrel,
• dabigatran, ticagrelor
• non-steroidal anti-inflammatory drugs (NSAIDS; excluded only for daily use)
• over-the-counter sleep medication (not categorized as sedatives, hypnotics or
• anti-depressants)
• anti-cholinergic drugs or acetylcholinesterase inhibitors: bethanechol
• (Urecholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl),
• neostigmine (Prostigmin)
• anti-histamines that cause drowsiness (eg. Ranitidine)
• pseudoephedrine and phenylephrine
• Currently taking (from day of screening onwards) dietary supplements that the
• Principal Investigator believes would interfere with the objectives of the study, pose
• a safety risk or confound the interpretation of the study results such as: melatonin,
• vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St. John's Wort
• or other cognitive enhancing dietary or herbal supplements over the study period.
• 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 or
• yoghurts/yoghurt drinks containing probiotics).
• Pregnant or lactating female, or pregnancy planned during intervention period.
• Have self-reported dyslexia.
• Current misuse of alcohol, drugs, or prescription medication.
• Current smoker.
• Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to
• screening and during the intervention period.
• Excessive alcohol consumption (drinking on 5 or more days a week) for 3 weeks prior to
• screening and during the intervention period.
• Contraindication to any substance in the investigational product.
• Participation in another study with any investigational product within 30 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.