Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change Scores on Working memory and attentional control
研究概览
简要总结
This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
详细描述
Probiotics has demonstrated to be effective in the management of anxiety and depression. Although these results are promising, more research is needed to explore the role of probiotics to improve physical, emotional and cognitive processes in different clinical populations that are associated with altered microbiome. Thus, the main aim of the present project is to explore whether the oral intake of probiotics might provide benefits to a group of patients with fibromyalgia.
The investigators expect to found significant differences between some physical, emotional and cognitive measures assessed pre- and post-treatment demonstrating the effects of microbiota on the Central Nervous System as well as its potential as a therapeutic tool for the treatment of Fibromyalgia.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia syndrome diagnosis.
- •No treatment with antibiotic.
- •More than a year of diagnosis
- •Agreement to participate in the study.
排除标准
- •Severe physical disability.
- •Malignancy.
- •Pregnancy
- •Psychiatric illnesses (eg, schizophrenia or substance abuse).
- •Medication usage other than as-needed analgesics (excluding long-term narcotics).
结局指标
主要结局
Change Scores on Working memory and attentional control
时间窗: Time Frame: At baseline and 8 weeks
Corsi task
次要结局
- Changes Scores on Heart rate variability.(Time Frame: At baseline and 8 weeks)
- Changes Scores on Systemic vascular resistance.(Time Frame: At baseline and 8 weeks)
- Change Scores on Quality of Life(Time Frame: At baseline and 8 weeks)
- Change Scores on Stress(Time Frame: At baseline and 8 weeks)
- Change Scores on Sleep Quality(Time Frame: At baseline and 8 weeks)
- Change Scores on Body Composition(Time Frame: At baseline and 8 weeks)
- Changes Scores on Valsalva ratio. K30/15.(Time Frame: At baseline and 8 weeks)
- Change Scores on Depression(Time Frame: At baseline and 8 weeks)
- Change Scores on Anxiety(Time Frame: At baseline and 8 weeks)
- Changes Scores on Cholinergic response indicators (%)(Time Frame: At baseline and 8 weeks)
- Change Scores on Pain(Time Frame: At baseline and 8 weeks)
- Change Scores on Impulsivity(Time Frame: At baseline and 8 weeks)
研究者
Pablo Román López
PhD Student
Universidad de Almeria