A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Score on the Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
This study aims to understand the efficacy of two probiotic interventions as prophylaxes of fibromyalgia symptoms in individuals diagnosed.
The primary outcome measure will be the progression and treatment of fibromyalgia, defined as a decrease in the Fibromyalgia Impact Questionnaire (FIQ) score, other otucomes will be the effect on the symptoms of anxiety and depression associated with fibromyalgia, defined as a decrease in the Hospital Anxiety and Depression Scale (HAD) score; perception of pain by scoring on a Visual Analogical Pain Scale (VAS), and differences in the patient's usual medical treatment. Finally adverse effects will be evaluated.
The study will have two arms: one arm including a probiotic preparation and a placebo arm.
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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 - 65 years.
- •Signature of informed consent by the patient.
- •Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia
排除标准
- •Women who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.
- •Known allergy to any of the components of the study product or the placebo.
- •Consumption of antibiotics in the 2 weeks prior to the start of the study.
- •Consumption of probiotics in the 2 months prior to the start of the study.
- •Evidence of neuropsychiatric disorders including: Parkinson's disease, psychotic disorder, bipolar depression
- •Regular consumption of alcohol in excess of 45 g ethanol/day in the year prior to study inclusion.
- •Any concurrent malignant pathology known at the time of inclusion in the study or serious metabolic, cardiovascular, renal, hepatic or gastrointestinal diseases which may lead to non-completion of the study according to the investigator's criteria.
结局指标
主要结局
Score on the Fibromyalgia Impact Questionnaire (FIQ)
时间窗: 12-week
Score on the Fibromyalgia Impact Questionnaire (FIQ), The score range is form 0 to 100, where each question has an score from 0 to 10. Higher scores refers a higher impact of fybromialgia in lifestile where 0 is the best functional capacity and higher quality of life and 100 the worst stat, in weeks 12.
次要结局
- Score on the Hospital Anxiety and Depression Scale (HAD)(12 weeks)
- Number of adverse events(12 weeks)
- Visual Analogical Pain Scale (VAS) Score(12 weeks)
- Changes to a patient's usual medical treatment for fibromyalgia(12 weeks)
- Treatment adherence rate(12 weeks)