Fatigue Syndrome, Chronic, Microbial Colonization
Conditions
Keywords
fatigue, microbiome
Brief summary
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)
Detailed description
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).
Interventions
PROCEDUREFaecal transplantation
Faecal transplantation from a healthy donor via colonoscopy
PROCEDUREPlacebo faecal transplantation
Placebo faecal transplantation containing patient's own feces via colonoscopy
Sponsors
University of Helsinki
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Blinded products, investigators and patients are blinded. Fecal transplant is either from a healthy donor or patient's own feces
Intervention model description
Double-blinded study, treatment group and placebo-group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
-Chronic Fatigue Syndrome
Exclusion criteria
* Other conditions causing chronic fatigue * Diseases affecting the intestinal system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Fatigue Scale | 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) |
| Health related quality of life assessed by EQ-5D-5L questionnaire | 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) |
| Health related quality of life assessed by 15D questionnaire | 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 | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life assessed by EQ-5D-5L questionnaire | Change from Baseline EQ-5D-5L scores at 1 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) |
| Health related quality of life assessed by 15D questionnaire | Change from Baseline 15D at 1 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 | Change from Baseline Modified Fatigue Impact Scale scores at 1 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 | Change from Baseline at 1 months after the procedure | Whether ability to work or study has been restored (value is 1) or not (value is 0) |
| Visual Analog Fatigue Scale | Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure | A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue) |
Countries
Finland
Outcome results
None listed