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Intestinal Microbiota and Chronic Fatigue Syndrome

Primary Purpose

Fatigue Syndrome, Chronic, Microbial Colonization

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Faecal transplantation

Placebo faecal transplantation

About this trial

This is an interventional treatment trial for Fatigue Syndrome, Chronic focused on measuring fatigue, microbiome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Chronic Fatigue Syndrome

Exclusion Criteria:

Other conditions causing chronic fatigue
Diseases affecting the intestinal system

Sites / Locations

Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fecal transplant

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

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)

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)

Ability to work or study

Whether ability to work or study has been restored (value is 1) or not (value is 0)

Visual Analog Fatigue Scale

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

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

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

Ability to work or study

Whether ability to work or study has been restored (value is 1) or not (value is 0)

Visual Analog Fatigue Scale

A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)

Full Information

NCT ID

NCT04158427

First Posted

August 8, 2019

Last Updated

April 27, 2022

Sponsor

Tampere University Hospital

Collaborators

University of Helsinki

1. Study Identification

Unique Protocol Identification Number

NCT04158427

Brief Title

Intestinal Microbiota and Chronic Fatigue Syndrome

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tampere University Hospital

Collaborators

University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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)

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue Syndrome, Chronic, Microbial Colonization

Keywords

fatigue, microbiome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Double-blinded study, treatment group and placebo-group

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Blinded products, investigators and patients are blinded. Fecal transplant is either from a healthy donor or patient's own feces

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fecal transplant

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Faecal transplantation

Intervention Description

Faecal transplantation from a healthy donor via colonoscopy

Intervention Type

Procedure

Intervention Name(s)

Placebo faecal transplantation

Intervention Description

Placebo faecal transplantation containing patient's own feces via colonoscopy

Primary Outcome Measure Information:

Title

Health related quality of life assessed by EQ-5D-5L questionnaire

Description

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

Title

Health related quality of life assessed by 15D questionnaire

Description

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

Title

Health related quality of life assessed by Modified Fatigue Impact Scale

Description

Time Frame

Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure

Title

Ability to work or study

Description

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

Title

Visual Analog Fatigue Scale

Description

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

Secondary Outcome Measure Information:

Title

Health related quality of life assessed by EQ-5D-5L questionnaire

Description

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 1 months after the procedure

Title

Health related quality of life assessed by 15D questionnaire

Description

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

Title

Health related quality of life assessed by Modified Fatigue Impact Scale

Description

Time Frame

Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure

Title

Ability to work or study

Description

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

Title

Visual Analog Fatigue Scale

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tapani Salonen, MD, PhD

Organizational Affiliation

Tampere University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tampere University Hospital

City

Tampere

ZIP/Postal Code

33520

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intestinal Microbiota and Chronic Fatigue Syndrome

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