Effect of Probiotic Food Supplement "GutMagnific™" in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Also Known as Post-viral Fatigue Syndrome, and Comorbid Gastrointestinal Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Changes in ME/CFS symptoms
研究概览
简要总结
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a neurological disease. Currently there is no effective treatment for ME/CFS due to unclear etiology of the disease. The aim of this randomized double-blind placebo-control clinical trial is to study the efficacy of the probiotic food supplement "GutMagnific™" in ME/CFS and comorbid gastrointestinal complications. The outcome of the study will be assessed based on the data from different self-reporting questionnaires and intestinal microbial flora analysis.
详细描述
Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) is a neurological disease with different symptoms such as fatigue. Symptoms get worse by physical or mental exertion which usually persists for more than 24 hours (post-exertional malaise, PEM). ME/CFS is often characterized by reduced functional capacity, worsening social relationships and reduced ability to cope with work or study.
The exact cause of the ME/CFS is presently unknown however a history of viral infection is common among ME/CFS patients. Prolonged post viral fatigue can develop into a chronic illness and ME/CFS. Current research strongly suggests involvement of gastrointestinal tract and gut microflora disturbances in the pathogenesis with strong evidence supporting the role of imbalance of gut microflora, damaged gut barrier functions and dysfunctional immune responses. There are some features shared with gastrointestinal conditions like irritable bowel syndrome (IBS). GutMagnific™ is an evidence-based probiotic food supplement, scientifically designed to be effective in correcting imbalances of the gut microflora, repairing a damaged gut barrier and reducing inflammation. The strain combination in GutMagnific™ has been carefully designed for its efficacy in IBS and therefore it can be reasonably expected to be also effective in ME/CFS.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Pre-masked randomized vegan capsules with probiotic "GutMagnific" in 2 different doses, or corresponding placebo
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
- •Clinical diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) at Stora Sköndals Neurological Rehabilitation Clinic
- •Gastrointestinal complications similar to IBS
排除标准
- •Consumption of any probiotics two weeks before enrolment
- •Consumption of other probiotic products during the trial
结局指标
主要结局
Changes in ME/CFS symptoms
时间窗: At the baseline and weekly for 4 months
ME/CFS symptom rating scale filled up weekly by participants, graded 0-4 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria. Higher score indicating worse outcome.
次要结局
- Changes in Irritable Bowel Syndrome (IBS) symptoms(At the baseline and weekly for 4 months)
- Changes in the gastrointestinal symptoms based on Rome III criteria(At the baseline and after 3 & 4 months)
- Changes in health related quality of life (RAND 36-Item Health Survey)(At the baseline and monthly for 4 months)
- Changes in Hospital Anxiety and Depression Scale (HADS)(At the baseline and after 3 & 4 months)
- Changes in gut microbiota composition(At the baseline and after 3 months)