Intestinal Microbiota and Chronic Fatigue Syndrome

Overview

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)

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2023

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).

Interventions

  • Procedure: Faecal transplantation
    • Faecal transplantation from a healthy donor via colonoscopy
  • Procedure: Placebo faecal transplantation
    • Placebo faecal transplantation containing patient’s own feces via colonoscopy

Arms, Groups and Cohorts

  • Experimental: Fecal transplant
    • A single dose fecal transplant is given (via colonoscopy) from a healthy donor
  • Placebo Comparator: Placebo
    • A single dose patient’s own feces is given (via colonoscopy)

Clinical Trial Outcome Measures

Primary Measures

  • Health related quality of life assessed by EQ-5D-5L questionnaire
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Health related quality of life assessed by EQ-5D-5L questionnaire
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)

Participating in This Clinical Trial

Inclusion Criteria

-Chronic Fatigue Syndrome

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tampere University Hospital
  • Collaborator
    • Helsinki University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tapani Salonen, Principal Investigator, MD, PhD – Tampere University Hospital
  • Overall Official(s)
    • Tapani Salonen, MD, PhD, Principal Investigator, Tampere University Hospital
  • Overall Contact(s)
    • Tapani Salonen, MD, PhD, +358 3 31165083, tapani.salonen@pshp.fi

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