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NCT Number: NCT04158427

Intestinal Microbiota and 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)

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Key information

Conditions

Fatigue Syndrome, Chronic Chronic Disease Communicable Diseases Disease Attributes Encephalomyelitis Fatigue Infections Microbial Colonization Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 33520, Finland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Chronic Fatigue Syndrome

Exclusion criteria

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

Treatment and study plan

Faecal transplantation

Procedure

Faecal transplantation from a healthy donor via colonoscopy

Placebo faecal transplantation

Procedure

Placebo faecal transplantation containing patient's own feces via colonoscopy

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 8, 2019
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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