Intestinal Microbiota and Chronic Fatigue Syndrome

Microbial Colonization Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158427
• Other study ID #: R18006
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

-Chronic Fatigue Syndrome

Exclusion Criteria:

• Other conditions causing chronic fatigue

• Diseases affecting the intestinal system

Related Conditions & MeSH terms

• Communicable Diseases
• Fatigue
• Fatigue Syndrome, Chronic
• Infections
• Microbial Colonization
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life assessed by EQ-5D-5L questionnaire	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)	Change from Baseline EQ-5D-5L scores at 6 months after the procedure
Primary	Health related quality of life assessed by 15D questionnaire	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)	Change from Baseline 15D scores at 6 months after the procedure
Primary	Health related quality of life assessed by Modified Fatigue Impact Scale	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)	Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure
Primary	Ability to work or study	Whether ability to work or study has been restored (value is 1) or not (value is 0)	Change from Baseline at 6 months after the procedure
Primary	Visual Analog Fatigue Scale	A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)	Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure
Secondary	Health related quality of life assessed by EQ-5D-5L questionnaire	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)	Change from Baseline EQ-5D-5L scores at 1 months after the procedure
Secondary	Health related quality of life assessed by 15D questionnaire	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)	Change from Baseline 15D at 1 months after the procedure
Secondary	Health related quality of life assessed by Modified Fatigue Impact Scale	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)	Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure
Secondary	Ability to work or study	Whether ability to work or study has been restored (value is 1) or not (value is 0)	Change from Baseline at 1 months after the procedure
Secondary	Visual Analog Fatigue Scale	A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)	Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure