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)
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Faecal transplantation from a healthy donor via colonoscopy
Placebo faecal transplantation containing patient's own feces via colonoscopy
Tampere University Hospital
Tampere, Finland
Health related quality of life assessed by EQ-5D-5L questionnaire
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)
Time frame: Change from Baseline EQ-5D-5L scores at 6 months after the procedure
Health related quality of life assessed by 15D questionnaire
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)
Time frame: Change from Baseline 15D scores at 6 months after the procedure
Health related quality of life assessed by Modified Fatigue Impact Scale
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)
Time frame: Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure
Ability to work or study
Whether ability to work or study has been restored (value is 1) or not (value is 0)
Time frame: Change from Baseline at 6 months after the procedure
Visual Analog Fatigue Scale
A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)
Time frame: Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure
Health related quality of life assessed by EQ-5D-5L questionnaire
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)
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Time frame: Change from Baseline EQ-5D-5L scores at 1 months after the procedure
Health related quality of life assessed by 15D questionnaire
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)
Time frame: Change from Baseline 15D at 1 months after the procedure
Health related quality of life assessed by Modified Fatigue Impact Scale
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)
Time frame: Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure
Ability to work or study
Whether ability to work or study has been restored (value is 1) or not (value is 0)
Time frame: Change from Baseline at 1 months after the procedure
Visual Analog Fatigue Scale
A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)
Time frame: Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure