A Randomized, Placebo-Controlled Pilot Study Evaluating a Probiotic Intervention for Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- VIRDIS: Rating of unpleasantness in a virtual reality social scenario
研究概览
简要总结
This randomized, double-blind, placebo-controlled pilot study will evaluate the effects of four weeks of supplementation with a probiotic on mental health in healthy adults aged 18-30 years. Participants will be randomized to receive either probiotic or placebo and will complete study assessments at baseline and end of intervention, and will complete a range of behavioral, physiological, and questionnaire-based assessments before and after the intervention. The primary objective is to assess the effect on emotional reactivity measured in a virtual reality scenario at the end of the intervention. This exploratory study is intended to generate data to inform future clinical research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-30 years of age
- •Native-level Danish language skills
- •No current psychiatric illness, confirmed with the Presence State Examination (PSE) and the Standardized Assessment of Personality (SAPAS)
- •No previous history of severe psychiatric illness, including bipolar disorder, recurrent unipolar depression, psychosis spectrum disorders, personality disorders, autism spectrum disorders, or attention deficit (hyperactivity) disorder (ADHD/ADD), confirmed with PSE and SAPAS. Participants may still be included if they have a history of a single depressive episode, or have experienced symptoms of anxiety, stress, or burnout more than 6 months ago.
排除标准
- •Recent use of probiotics (within the past 4 weeks)
- •Use of antibiotics within the past 3 months
- •Smoking, chewable tobacco, vaping, or use of other nicotine products
- •Neurological disorders (including dementia)
- •Use of psychotropic medication within the previous 6 months, including:
- •Anxiolytics
- •Antidepressants
- •Antipsychotics
- •Anticonvulsants
- •Centrally acting corticosteroids
- •Opioid pain relievers
- •Hypnotics
- •Prescribed sleep medications or herbal sleep aids (e.g., valerian)
- •Severe physical illness, including:
- •Cardiovascular disease
- •Gastrointestinal pathology (e.g., colon cancer, colitis, Crohn's disease)
- •Gynecological pathology (e.g., endometriosis)
- •Urologic pathology (e.g., prostate cancer)
- •Severely immunocompromised status, including:
- •HIV positive
- •Being a transplant recipient
- •Use of anti-rejection medication
- •Use of steroids for more than 30 days
- •Chemotherapy or radiotherapy within the last year
- •Current alcohol or substance abuse disorder
- •Previous severe head trauma
- •History of epilepsy
- •Pregnancy or breastfeeding
- •Known allergy to any component of the test product
- •Participation in a clinical study with another investigational product within 60 days before screening, or plans to participate in another study during the study period
- •Significant change in dietary habits within the previous 4 weeks (e.g., starting a fibre-enriched diet)
- •Planned major changes in diet or exercise habits during the study period
- •Current pregnancy
研究组 & 干预措施
Probiotic
Daily oral supplementation of probiotic for 4 weeks
干预措施: Probiotic (Dietary Supplement)
Placebo
Daily oral supplementation of placebo for 4 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
VIRDIS: Rating of unpleasantness in a virtual reality social scenario
时间窗: This outcome is assessed only at treatment completion (at week 4).
Participants complete a virtual reality-based assessment (VIRDIS) and rate their level of unpleasantness following exposure to a predefined social scenario. Unpleasantness is assessed on a 5-point scale ranging from 1 (not at all unpleasant) to 5 (very unpleasant).
次要结局
- VIRDIS: a composite score of ratings of unpleasantness across all virtual reality scenarios(This outcome is assessed only at treatment completion (at week 4))
- VIRDIS: heart rate(This outcome is assessed only at treatment completion (at week 4).)
- Short Form 36 - Energy/Vitality subscale(Change from baseline to treatment completion (at week 4))
研究者
Kamilla Woznica Miskowiak
Professor, DMSc, DPhil, Head of the NEAD Centre
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital