Dysbiosis in Bipolar Disorder: MicrObiota Bipolar Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Composition of the gut microbiota.
研究概览
简要总结
The gut microbiota is a complex community comprising around 10^14 bacteria that live in the gut lumen. The imbalance of the normal structure and function of the microbiota, defined as dysbiosis, has been related to a wide diversity of pathologies, including mental health disorders. However, clinical evidence of the relationship between microbiota and mood disorders is lacking. The aim of this project is to examine the possible relationship of gut dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and of gut dysbiosis and cognitive impairment in bipolar patients.
详细描述
A prospective longitudinal study will be carried out with three groups of patients: a group of euthymic bipolar I or II patients without cognitive impairment (n=50), a second group of euthymic bipolar I or II patients with cognitive impairment (n=50) and a control group of healthy volunteers (n=50). Cognitive impairment will be defined as performance in any test of a domain below 2 standard deviations or more from the mean of normative data of each test assessed in the control group. Subjects will be recruited in the Hospital Clinic of Barcelona. At baseline clinical variables and diet patterns (ROME III) will be collected and neuropsychological performance (WCST, FAS, Stroop Colour-Word Interference test, TMT, WAIS-III, CVLT-II) and functionality (FAST) will be assessed. All subjects will be reassessed at 12 months follow-up. The mood state and possible affective relapses will be evaluated and treatments will be registered. All patients will receive standard psychiatric care according to international guidelines on bipolar disorders. Fecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and stored at -80°C until assayed. Sequencing will be performed on an Illumina MiSeqTM platform. Statistical analysis will be performed with the latest existing version of the SPSS.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients:
- •Diagnosis of bipolar disorder type I or II according to DSM-IV criteria (SCID);
- •Age between 18-55 years;
- •Euthymia (YMRS<6 and HMDRS<8) for at least 3 months;
- •Signed informed consent.
- •Healthy controls:
- •No psychiatric diagnosis (SCID);
- •Age between 18-55 years; euthymia (YMRS<6 and HMDRS<8);
- •Signed informed consent.
排除标准
- •Use of any type of antibiotics, antifungals or pro/prebiotics within at least one month prior to recruitment;
- •Neurological illness;
- •Stomach/gut problems;
- •Current diagnosis of substance abuse or dependence according to DSM-IV criteria (SCID);
- •Electroconvulsive therapy in the last year.
结局指标
主要结局
Composition of the gut microbiota.
时间窗: 12 months
To determine if patients diagnosed with BD present gut dysbiosis compared to controls through genome sequencing of fecal samples.
次要结局
- Composition of the gut microbiota according to mood state.(12 months)
- Composition of the gut microbiota according to cognitive state.(12 months)
研究者
Iria Grande
Principal Investigator
Hospital Clinic of Barcelona