Probiotics and Prebiotics as a Potential Treatment in Fibromyalgia Patients: A Randomized, Double-Blinded, Placebo-Controlled
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The aim of the present study is to determine the effectiveness of probiotic and prebiotic treatments in patients with fibromyalgia syndrome.
详细描述
Fifty-three, fibromyalgia syndrome participants were randomized to receive either: 1) probiotic 4×1010 CFUs per day 2) 10 g dose prebiotic (inulin) per day or 3) placebo for 8 wk. Fibromyalgia Impact Questionnaire (FIQ), Visual Analogical Pain Scale (VAS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburg Sleep Quality Index (PSQI) and quality of life (SF-36) were measured during the baseline, 4 weeks and 8 weeks intervention phases. Finally, the adverse effects will be evaluated.
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
Patients and investigators are double-blinded
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 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.
- •Participants should be diagnosed with fibromyalgia at least 1 year ago.
排除标准
- •using of antibiotic and nutritional supplements
- •being pregnant or breastfeeding
- •the presence of any allergies
- •being involved in any medical or psychological research
- •the presence of severe gastrointestinal diseases
- •psychiatric illness other than depression and anxiety.
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: 8 weeks
Fibromyalgia Impact Questionnaire (FIQ) form is a evaluate the functional status of the patients. In this scale, 10 different features are measured: physical function, well-being, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. The scale is scored range 0-100. Low scores indicated recovery except for the feeling of well-being.
次要结局
- Visual Analogue Scale (VAS)(8 weeks)
- Beck Depression Inventory (BDI)(8 weeks)
- Beck Anxiety Inventory (BAI)(8 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(8 weeks)
- SF-36 Quality of Life(8 weeks)
研究者
Nazlı Nur ASLAN ÇİN, PhD
Research Assistant in Department of Nutrition and Dietetics
Ankara University