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Intestinal Microbiota and Chronic Fatigue Syndrome

NCT04158427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-04-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Tapani Salonen, MD, PhD · Tampere University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158427 on ClinicalTrials.gov