Intestinal Microbiota and Chronic Fatigue Syndrome

Sponsor

Tampere University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04158427

Collaborator

University of Helsinki (Other)

Enrollment

Location

Arms

26.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Fatigue Syndrome, Chronic Microbial Colonization	Procedure: Faecal transplantation Procedure: Placebo faecal transplantation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-blinded study, treatment group and placebo-groupDouble-blinded study, treatment group and placebo-group

Masking:

Quadruple (Participant, Care Provider, 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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Fecal transplant

A single dose fecal transplant is given (via colonoscopy) from a healthy donor

Procedure: Faecal transplantation

Faecal transplantation from a healthy donor via colonoscopy

Placebo Comparator: Placebo

A single dose patient's own feces is given (via colonoscopy)

Procedure: Placebo faecal transplantation

Placebo faecal transplantation containing patient's own feces via colonoscopy

Outcome Measures

Primary Outcome Measures

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)
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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

-Chronic Fatigue Syndrome

Exclusion Criteria:

Other conditions causing chronic fatigue
Diseases affecting the intestinal system

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital	Tampere		Finland	33520

Sponsors and Collaborators

Tampere University Hospital
University of Helsinki

Investigators

Principal Investigator: Tapani Salonen, MD, PhD, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tapani Salonen, Principal Investigator, MD, PhD, Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT04158427

Other Study ID Numbers:

R18006

First Posted:

Nov 8, 2019

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tapani Salonen, Principal Investigator, MD, PhD, Tampere University Hospital

fatigue

microbiome

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic

Communicable Diseases

Infections

Syndrome

Fatigue

Study Results

No Results Posted as of Apr 28, 2022