Intestinal Microbiota and Chronic Fatigue Syndrome. Effect of Fecal Transplant on Health Related Quality of Life of the Patients With Chronic Fatigue Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Health related quality of life assessed by 15D questionnaire
研究概览
简要总结
Gut microbiota of 1) patients with chronic fatigue syndrome and 2) their healthy family members are analyzed.
Up to 40 patients with chronic fatigue syndrome are randomized to receive either 1) a faecal transplant from a healthty donor or 2) their own feces via colonoscopy. Patient's health related quality and ability to work are assessed (baseline, 1 and 6 months after the procedure)
详细描述
Patients with chronic fatigue syndrome (CFS) and their healthy family members (living together in the same house) are recruited in the study. CFS has been diagnosed in Tampere University Hospital and the diagnosis is based on thorough clinical assessment fulfilling the Institute of Medicine 2015 criteria. Patients microbiota is analyzed (microbiological analysis, mediators of inflammation) and results are compared with their family members.
Via colonoscopy, up to 40 patients with CFS are randomized to receive either a faecal transplant from a healthy donor (treatment group) or his/her own feces (placebo group). Products are blinded, investigators and patients are blinded. Patients' health related quality of life and ability to work or study are assessed (baseline, 1 and 6 months after the procedure).
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)
盲法说明
Blinded products, investigators and patients are blinded. Fecal transplant is either from a healthy donor or patient's own feces
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Fatigue Syndrome
排除标准
- •Other conditions causing chronic fatigue
- •Diseases affecting the intestinal system
结局指标
主要结局
Health related quality of life assessed by 15D questionnaire
时间窗: Change from Baseline 15D scores at 6 months after the procedure
Health related quality of life, 15D scores (15 separate dimensions, scale from 1 to 5; 1=the highest/best level), 5=the lowest/worst level)
Health related quality of life assessed by Modified Fatigue Impact Scale
时间窗: Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure
Health related quality of life, Modified Fatigue Impact Scale scores (Total Score, range 0 to 84; Physical subscale, range 0 to 36; Cognitive Subscale, range 0 to 40; Psychosocial Subscale, range from 0 to 8 (0 = no fatigue, highest points = extreme fatigue)
Ability to work or study
时间窗: Change from Baseline at 6 months after the procedure
Whether ability to work or study has been restored (value is 1) or not (value is 0)
Health related quality of life assessed by EQ-5D-5L questionnaire
时间窗: Change from Baseline EQ-5D-5L scores at 6 months after the procedure
Health related quality of life, Euro-QoL 5 Dimension (EQ-5D-5L scores) (5 levels of perceived problems, scale from 1 (no problems/the best) to 5 (extreme problems/unable to)
Visual Analog Fatigue Scale
时间窗: Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure
A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)
次要结局
- Health related quality of life assessed by Modified Fatigue Impact Scale(Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure)
- Health related quality of life assessed by 15D questionnaire(Change from Baseline 15D at 1 months after the procedure)
- Visual Analog Fatigue Scale(Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure)
- Health related quality of life assessed by EQ-5D-5L questionnaire(Change from Baseline EQ-5D-5L scores at 1 months after the procedure)
- Ability to work or study(Change from Baseline at 1 months after the procedure)
研究者
Tapani Salonen
Principal Investigator, MD, PhD
Tampere University Hospital