Clinical trial NCT04158427: Intestinal Microbiota and Chronic Fatigue Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Microbial Colonization
Keywords: fatigue
microbiome
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2019-11-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded study, treatment group and placebo-group
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

-Chronic Fatigue Syndrome

Exclusion Criteria:

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

Primary outcomes:
measure: Health related quality of life assessed by EQ-5D-5L questionnaire
timeFrame: Change from Baseline EQ-5D-5L scores at 6 months after the procedure
measure: Health related quality of life assessed by 15D questionnaire
timeFrame: Change from Baseline 15D scores at 6 months after the procedure
measure: Health related quality of life assessed by Modified Fatigue Impact Scale
timeFrame: Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure
measure: Ability to work or study
timeFrame: Change from Baseline at 6 months after the procedure
measure: Visual Analog Fatigue Scale
timeFrame: Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure
Secondary outcomes:
measure: Health related quality of life assessed by EQ-5D-5L questionnaire
timeFrame: Change from Baseline EQ-5D-5L scores at 1 months after the procedure
measure: Health related quality of life assessed by 15D questionnaire
timeFrame: Change from Baseline 15D at 1 months after the procedure
measure: Health related quality of life assessed by Modified Fatigue Impact Scale
timeFrame: Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure
measure: Ability to work or study
timeFrame: Change from Baseline at 1 months after the procedure
measure: Visual Analog Fatigue Scale
timeFrame: Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Tapani Salonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: