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Intestinal Microbiota and Chronic Fatigue Syndrome

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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

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intestinal Microbiota and Chronic Fatigue Syndrome
Official Title  ICMJE Intestinal Microbiota and Chronic Fatigue Syndrome. Effect of Fecal Transplant on Health Related Quality of Life of the Patients With Chronic Fatigue Syndrome
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Fatigue Syndrome, Chronic
  • Microbial Colonization
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Fecal transplant
    A single dose fecal transplant is given (via colonoscopy) from a healthy donor
    Intervention: Procedure: Faecal transplantation
  • Placebo Comparator: Placebo
    A single dose patient's own feces is given (via colonoscopy)
    Intervention: Procedure: Placebo faecal transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-Chronic Fatigue Syndrome

Exclusion Criteria:

  • Other conditions causing chronic fatigue
  • Diseases affecting the intestinal system
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04158427
Other Study ID Numbers  ICMJE R18006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tapani Salonen, Tampere University Hospital
Study Sponsor  ICMJE Tampere University Hospital
Collaborators  ICMJE University of Helsinki
Investigators  ICMJE
Principal Investigator: Tapani Salonen, MD, PhD Tampere University Hospital
PRS Account Tampere University Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP