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Intestinal Microbiota and Chronic Fatigue Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158427
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
University of Helsinki
Information provided by (Responsible Party):
Tapani Salonen, Tampere University Hospital

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-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 : January 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Chronic Fatigue Syndrome

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158427


Locations
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Finland
Tampere University Hospital
Tampere, Finland, 33520
Sponsors and Collaborators
Tampere University Hospital
University of Helsinki
Investigators
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Principal Investigator: Tapani Salonen, MD, PhD Tampere University Hospital
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Responsible Party: Tapani Salonen, Principal Investigator, MD, PhD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT04158427    
Other Study ID Numbers: R18006
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tapani Salonen, Tampere University Hospital:
fatigue
microbiome
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases