Intestinal Microbiota and Chronic Fatigue Syndrome

Not Applicable

Completed

• Conditions: Fatigue Syndrome, Chronic; Microbial Colonization
• Interventions: Procedure: Faecal transplantation; Procedure: Placebo faecal transplantation

• Registration Number: NCT04158427
• Lead Sponsor: Tampere University Hospital

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).

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-08
• Study Start: 2020-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

-Chronic Fatigue Syndrome

Exclusion Criteria

• Other conditions causing chronic fatigue
• Diseases affecting the intestinal system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal transplant	Faecal transplantation	A single dose fecal transplant is given (via colonoscopy) from a healthy donor
Placebo	Placebo faecal transplantation	A single dose patient's own feces is given (via colonoscopy)

Primary Outcome Measures

Name	Time	Method
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)
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)
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)

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)
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)
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)

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland