ACTRN12618001457235已完成2 期
Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1. Male or female, aged 18-50 years, inclusive.
- •2. Willing and able to provide written informed consent.
- •3. 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.
- •4. Agreement to comply with the protocol and study restrictions.
- •5. Available for all study visits.
- •6. Females of child-bearing potential required to provide a negative urine pregnancy test
- •and be using effective contraception (e.g. surgically sterilized (tubal ligation or
- •hysterectomy or partner is post-vasectomy, with sterility confirmed) or use an IUD
- •(intrauterine device), a diaphragm or condom combined with contraceptive sponge, foam or jelly, or be using an oral contraceptive (the pill) for at least 2 cycles before
- •the Screening-visit (Visit 0)).
- •7. Fluent in written and spoken English.
- •8. In good general health as judged by the Investigator/Clinical advisor based on medical
- •9. Must have normal, or corrected to normal vision.
- •10. Body mass index between 18.5 and 29.9kg/m2 (inclusive).
- •11. Participant is willing to maintain habitual diet (including caffeine and alcohol) and
- •physical activity patterns throughout the study period.
- •12. Participant is willing and able to comfortably abstain from caffeine for 10 hours
- •prior to and throughout the test visits, (2-3 hours).
- •13. Participant is willing to abstain from alcohol for 12 hours and vigorous physical
- •activity for 12 hours prior to all study visits.
排除标准
- •1. History of dementia, stroke and other neurological conditions.
- •2. Traumatic loss of consciousness in the last 12 months.
- •3. History of epilepsy or Parkinson's disease.
- •4. 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.
- •5. 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.
- •6. Uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood
- •pressure >100 mm Hg).
- •7. 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).
- •8. 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
- •9. 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.
- •10. Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during
- •the intervention period.
- •11. 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).
- •12. Pregnant or lactating female, or pregnancy planned during intervention period.
- •13. Have self-reported dyslexia.
研究者
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