Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder: Tracing a Subtype of Depression With Underlying Neurodegeneration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Composition of gut microbiota
研究概览
简要总结
The purpose of this study is to identify the variations in gut microbiota compositions between two subtypes of major depressive disorder.
详细描述
Objective
To identify the variations in gut microbiota compositions between two subtypes of major depressive disorder (MDD), namely those with and without REM sleep behavior disorder (RBD). To correlate the microbiota composition with depressive severity and prodromal markers of α-synucleinopathy.
Design: Case-control study Setting: Established clinical cohorts consisting of patients with comorbid MDD+RBD and MDD only and a group of sexand age-matched healthy control Participants: Patients with comorbid MDD+RBD (n=55), patients with MDD only (n=55), and healthy control (n=55).
Main outcome measures: The abundance and composition of gut microbiota, severity of depressive symptoms, and prodromal markers of α-synucleinopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Age-and sex-matched with MDD+RBD subjects;
- •Free of psychiatric disorders based on M.I.N.I.;
- •Without a personal history or a family history of RBD or neurodegenerative diseases (i.e. dementia and PD)
- •Free of RBD symptoms or RWSA by vPSG
排除标准
- •Presence of narcolepsy and other neurodegenerative diseases that may give rise to RBD and RWSA;
- •Severe psychiatric illness that could not permit a valid written informed consent or otherwise is not suitable for participating in a study;
- •Use of antibiotics within one month and the use of probiotics within three days prior to sample collection;
- •Pre-existing or post-operation of gastrointestinal diseases (e.g. inflammatory bowel disease, gastrointestinal cancer).
结局指标
主要结局
Composition of gut microbiota
时间窗: Day 0
Colonic fecal bacterial composition across two heterogeneous groups of MDD (with and without RBD) and a group of the sex- and age-matched healthy controls
次要结局
未报告次要终点
研究者
Professor Wing Yun Kwok
Professor
Chinese University of Hong Kong