Intestinal Microbiota and Chronic Fatigue Syndrome

Tampere University Hospital

Status: Completed

Conditions: Fatigue Syndrome, Chronic; Microbial Colonization

Treatments: Procedure: Placebo faecal transplantation; Procedure: Faecal transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04158427

R18006

Details and patient eligibility

About

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)

Full 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).

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Chronic Fatigue Syndrome

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Fecal transplant

Experimental group

Description:

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

Treatment:

Procedure: Faecal transplantation

Placebo

Placebo Comparator group

Description:

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

Treatment:

Procedure: Placebo faecal transplantation