Intestinal Microbiota and Chronic Fatigue Syndrome

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

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)

Study Overview

• Status: Completed
• Conditions: Microbial Colonization; Fatigue Syndrome, Chronic
• Intervention / Treatment: Procedure: Faecal transplantation; Procedure: Placebo faecal transplantation

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-Chronic Fatigue Syndrome

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: University of Helsinki
• Investigators: Principal Investigator: Tapani Salonen, MD, PhD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: fatigue; microbiome
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Disease Attributes; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Infections; Communicable Diseases; Fatigue Syndrome, Chronic
• Other Study ID Numbers: R18006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No