Intestinal Microbiota and Chronic Fatigue Syndrome

Study Overview
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Brief Summary
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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
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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).

Official Title
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Intestinal Microbiota and Chronic Fatigue Syndrome. Effect of Fecal Transplant on Health Related Quality of Life of the Patients With Chronic Fatigue Syndrome

Conditions
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Fatigue Syndrome, Chronic, Microbial Colonization

Intervention / Treatment
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* Procedure: Faecal transplantation
* Procedure: Placebo faecal transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Chronic Fatigue Syndrome Exclusion Criteria: Other conditions causing chronic fatigue Diseases affecting the intestinal system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded study, treatment group and placebo-group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal transplant<br>A single dose fecal transplant is given (via colonoscopy) from a healthy donor | Procedure: Faecal transplantation<br>* Faecal transplantation from a healthy donor via colonoscopy<br>|
| Placebo Comparator: Placebo<br>A single dose patient's own feces is given (via colonoscopy) | Procedure: Placebo faecal transplantation<br>* Placebo faecal transplantation containing patient's own feces via colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, microbiome