The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Mood
研究概览
简要总结
This study will be an 8-week open-label pilot study examining subjective and objective changes in mood, anxiety, cognition, and sleep before and after the introduction of a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10 treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to examine the full composition of the micro biome, the investigators will also be collecting and analyzing fecal samples as well as blood samples to examine changes in plasma levels of inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms of any changes seen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder (MDD) by Mini International Neuropsychiatric Interview (MINI)
- •Current depressive episode with a MADRS score of ≥ 20
- •Males and females between ages 18 and 65
- •Able to understand and comply with the requirements of the study
- •Provision of written informed consent
排除标准
- •Use of any antidepressant drug
- •Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
- •Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period)
- •Milk, yeast, or soy allergy
- •History of alcohol or substance abuse in the past 6 months
- •Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
- •Use of any type of laxative
- •Consumption of products fortified in probiotics
- •Severely suicidal
- •Experiencing psychosis or bipolar episode
- •History of epilepsy or uncontrolled seizures
研究组 & 干预措施
Participant
All participants will be experimental and receive Probio'Stick.
干预措施: Probio'Stick (Dietary Supplement)
结局指标
主要结局
Mood
时间窗: 8 weeks
Mood will be assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score of 12 indicating remission.
次要结局
- Cognition(8 weeks)
- Sleep(8 weeks)
- Plasma(8 weeks)
- Anxiety(8 weeks)
研究者
Dr. Roumen Milev
Psychiatrist
Queen's University