Intestinal Microbiota and Chronic Fatigue Syndrome

NCT04158427 | Completed

• 1 other identifier: R18006
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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)

Conditions

Fatigue Syndrome, Chronic; Microbial Colonization

Keywords

fatigue; microbiome

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Health related quality of life assessed by EQ-5D-5L questionnaire

  Change from Baseline EQ-5D-5L scores at 1 months after the procedure

• Health related quality of life assessed by 15D questionnaire

  Change from Baseline 15D at 1 months after the procedure

• Health related quality of life assessed by Modified Fatigue Impact Scale

  Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure

• Ability to work or study

  Change from Baseline at 1 months after the procedure

• Visual Analog Fatigue Scale

  Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure

Study Arms (2)

Fecal transplant

EXPERIMENTAL

A single dose fecal transplant is given (via colonoscopy) from a healthy donor

Procedure: Faecal transplantation

Placebo

PLACEBO COMPARATOR

A single dose patient's own feces is given (via colonoscopy)

Procedure: Placebo faecal transplantation

Interventions

Faecal transplantation PROCEDURE

Faecal transplantation from a healthy donor via colonoscopy

Fecal transplant

Placebo faecal transplantation PROCEDURE

Placebo faecal transplantation containing patient's own feces via colonoscopy

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Fatigue Syndrome

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

Location

Related Publications (1)

• Salonen T, Jokinen E, Satokari R, Lahtinen P. Randomized, double-blinded, placebo-controlled pilot study: efficacy of faecal microbiota transplantation on chronic fatigue syndrome. J Transl Med. 2023 Jul 29;21(1):513. doi: 10.1186/s12967-023-04227-y.

  PMID: 37516837 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Communicable Diseases; Fatigue

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Tapani Salonen, MD, PhD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded products, investigators and patients are blinded. Fecal transplant is either from a healthy donor or patient's own feces
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: Double-blinded study, treatment group and placebo-group

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: November 8, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)