Double-blind Placebo-controlled Clinical Trial of Lactobacillus Helveticus as an add-on Strategy for the Treatment of Major Depression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in the depressive symptoms severity
研究概览
简要总结
The main objective of the study is to evaluate whether the association of the probiotic Lactobacillus helveticus to standard antidepressant will contribute to the treatment of major depression.
详细描述
Patients with the diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria will receive one daily oral dose of 1 × 10^9 colony-forming units (CFUs) of Lactobacillus helveticus or placebo for 8 weeks in addition to conventional antidepressant treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged between 18 and 65 years old;
- •Diagnosis of major depression
- •Agree to sign the informed consent.
排除标准
- •Treatment with anti-inflammatory drugs or antibiotics of any pharmacological classes in the month before treatment enrollment;
- •Use of dietary supplementation (herbal supplements, other pro- or prebiotics).
结局指标
主要结局
Change in the depressive symptoms severity
时间窗: 8 weeks
Depression symptoms severity will be assessed through the Montgomery-Asberg Depression Rating Scale (MADRS) (Minimum: 0 to 6 - normal/symptom absent/ Maximum: \>34 - severe depression). Higher scores mean a worse outcome.
次要结局
- Change in perception of stress(8 weeks)
- Change in microbiota composition(8 weeks)
- Changes in the serum levels of biomarkers(8 weeks)
研究者
Antonio L Teixeira Jr
Principal Investigator
Federal University of Minas Gerais