Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder and Possible Mediating Effects of Systemic and Intestinal Inflammatory Markers in the Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Outcome
研究概览
简要总结
Bipolar Disorder (BD) is highly incapacitating and associated with premature mortality. Depressive symptoms and episodes are the most frequent cause of disability in subjects with BD and over half of patients do not respond adequately to approved treatments for this condition, showing the need for new classes of treatments to complement current pharmacotherapy. Previous studies demonstrated that the intestinal flora have potential positive or negative effects on the Central Nervous System and suggest that adding specific strains of bacteria to people's diet may have antidepressant properties.The study proposes to evaluate the clinical benefit of adding probiotics to pharmacological treatments for bipolar depression. This will be a study with 124 subjects (62 receiving probiotics and 62 placebo). The research team in this department has focused especially on non-pharmacological treatments for bipolar disorder (psychotherapy, nutrition and exercise) and is multidisciplinary in scope with psychiatrists, psychologists, nurses, physiotherapists and nutritionists participating in research projects.
详细描述
It will test, in a proof-of-concept study, the antidepressant efficacy of adjunctive administration of probiotics in bipolar depression and evaluate potential inflammatory and metabolic markers associated with response to treatment. With this objective, 84 individuals with bipolar disorder type I or type II presenting subsyndromal depressive symptoms or a major depressive episode will be recruited. The study design lasts 12 weeks and is expected to last two years.
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)
盲法说明
All blind clinical assessments will be done by Psychiatrists, members of the University of São Paulo (USP) Bipolar Research Program managed by Michelle Flores. In this study, the intervention will be double-blind: All participants will receive the exact same pill, whether placebo or intervention, with equal packaging-manufacturing.
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
- •BD type I or type II, according to the use of Mini Internacional Neuropsychiatric Interview (MINI)
- •Score on the Young Mania Rating Scale (YMRS) < 8
- •Score on the Montgomery-Asberg Depression Rating Scale (MADRS) > 8
- •Be receiving major guideline-approved treatments for bipolar depression for at least 4 weeks
排除标准
- •Pregnant or lactating women
- •Substance or alcohol dependence
- •Patients on prolonged antibiotic therapy, immunosuppressive therapies
- •A recent introduction of antidepressants in the last 15 days
- •Use of another probiotic, either in the form of food, sachets, capsules and others
研究组 & 干预措施
Probiotic group
In addition to the usual medication treatment for bipolar disorder, following the main international guidelines for the treatment of bipolar disorder, subjects will receive food supplementation with a probiotic formulation, twice daily, with food. We will use Pendulum Therapeutics' Glucose Control, probiotic formulation patented in the United States.
Probiotic Ingredients: Clostridium butyricum WB-STR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WB-STR-0001, and Bifidobacterium infantis.
The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)
干预措施: Probiotic Group (Other)
Placebo Group
In addition to the usual medication treatment for bipolar disorder, following the main international guidelines for the treatment of bipolar disorder, the subjects will receive food supplementation with a placebo formulation, twice daily, with food We will use Pendulum Therapeutics' placebo formulation that contains:
Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)
干预措施: Placebo Group (Other)
结局指标
主要结局
Outcome
时间窗: 12 weeks
The Montgomery-Asberg Depression Rating Scale (MADRS) will be used in order to evaluate the reduction of depressive symptoms. Response to treatment at week-12 will be defined as ≥ 50% reduction in total MADRS total score from baseline. Remission will be defined as MADRS total score ≤ 12.
次要结局
未报告次要终点
研究者
Beny Lafer
Principal Investigator
University of Sao Paulo