Efficacy and Tolerability of the Probiotic VSL#3 for the Treatment of Patients With Fibromyalgia and Associated Gastrointestinal Symptomatology: a Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change, From Baseline to Endpoint (12 Weeks) in the Composite Score of Abdominal Pain, Abdominal Bloating and Metheorism Each One Measured in a 0-10 Visual Analog Scale
研究概览
简要总结
The study evaluated the efficacy and tolerability of probiotic VSL#3 for the treatment of gastrointestinal symptoms in patients with fibromyalgia; 50% of the participants received probiotic and the remaining 50% received matching placebo in a double-blind, randomized design.The treatment was administered during a 12-week period and the participants were followed for an additional 12-week period in order to follow the evolution after treatment.
详细描述
Many patients with fibromyalgia experience associated gastrointestinal symptomatology such as abdominal pain, abdominal bloating, meteorism, diarrhea and/or constipation. To date there is not any specific treatment for these symptoms that markedly impair the quality of life of these subjects. This trial intended to investigate if the addition of a polymicrobial probiotic product, which has shown efficacy in patients with irritable bowel syndrome, was also be useful to ameliorate the gastrointestinal symptomatology of patients with 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed of fibromyalagia
- •experiencing at least 3 chronic gastrointestinal symptoms
- •signed informed consent to participate
- •accept to not change previously prescribed treatment during study duration
排除标准
- •mental illness excepting depression
- •severe organic disease
- •additional gastrointestinal disease excepting irritable bowel syndrome
- •pregnancy
- •breastfeeding
结局指标
主要结局
Change, From Baseline to Endpoint (12 Weeks) in the Composite Score of Abdominal Pain, Abdominal Bloating and Metheorism Each One Measured in a 0-10 Visual Analog Scale
时间窗: baseline and twelve weeks after treatment
Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 12 score - baseline score)
次要结局
- Change From Week 12 to Week 16 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment(Week 12 to week 16)
- Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI)(baseline and twelve weeks after treatment)
- Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS(baseline and twelve weeks after treatment)
- Number of Patients Considered as Responders to Treatment(Baseline and 12 weeks after treatment)
- Change From Week 12 to Week 20 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment(Week 12 to week 20)
- Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR)(baseline and twelve weeks after treatment)
- Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS(baseline and 12 weeks after treatment)
- Change From Week 12 to Week 24 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment(Week 12 to week 24)
- Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9)(baseline and twelve weeks after treatment)
研究者
Elena Pita Calandre
professor
Universidad de Granada