Effect of Probiotic on Depressive Symptom in Chinese Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
Depressive disorder, also known as depression, is a type of mood disorder characterized by persistent low mood. The incidence of depression worldwide is about 6%. Growing evidence suggested that the gut microbiota plays a key role in the development of depression. Probiotics can effectively regulate gut microbiota, and showed potential in alleviating depression. This study investigated the effect of formula probiotic (containing Lactobacillus paracasei, Bifidobacterium animalis, Bifidobacterium longum, Bifidobacterium bifidum and Lactobacillus plantarum) on depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal body mass index ≥ 18.5 until ≤ 29.9
- •Mild to moderate major depression diagnosed by psychiatrists according to the diagnostic criteria for depressive episodes in DSM-5 (American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition))
- •Hamilton Rating Scale for Depression (HAMD-17) score not less than 8
- •Agreed to intake study product during the study period
- •Agreed to sign written informed consent
排除标准
- •Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study
- •Investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements
- •Persons with a milk protein allergy, lactose intolerance
- •Pregnant or breastfeeding women
- •Subject had other serious diseases
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: Changes in the HAMD score at baseline and 8-week intervention
Depressive symptoms as measured with the Hamilton Rating Scale for Depression. The score rangs from 0 to 53. The higher score means severer depressive symptoms.
次要结局
- Serum TNF-α(change from baseline to intervention measurements at 8 weeks)
- Fecal microbiome(Changes between at baseline and 8-week intervention)
- Serum Il-1β(change from baseline to intervention measurements at 8 weeks)
- Serum cortisol(change from baseline to intervention measurements at 8 weeks)
- Serum Brain-derived neurotrophic factor(change from baseline to intervention measurements at 8 weeks)
- Serum Il-6(change from baseline to intervention measurements at 8 weeks)
研究者
Fazheng Ren
professor
China Agricultural University