Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
13 participants
INTERVENTIONAL
2020-01-01
2022-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fecal Transplantation in Ulcerative Colitis
NCT03561532
Fecal Microbiota Transplantation in Postoperative Crohn's Disease
NCT04637438
Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
NCT02390726
Impact of Fecal Microbiota Transplantation in Ulcerative Colitis
NCT03483246
Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
NCT04687150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fecal transplant
A single dose fecal transplant is given (via colonoscopy) from a healthy donor
Faecal transplantation
Faecal transplantation from a healthy donor via colonoscopy
Placebo
A single dose patient's own feces is given (via colonoscopy)
Placebo faecal transplantation
Placebo faecal transplantation containing patient's own feces via colonoscopy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Faecal transplantation
Faecal transplantation from a healthy donor via colonoscopy
Placebo faecal transplantation
Placebo faecal transplantation containing patient's own feces via colonoscopy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Diseases affecting the intestinal system
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Helsinki
OTHER
Tampere University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tapani Salonen
Principal Investigator, MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tapani Salonen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tampere University Hospital
Tampere, , Finland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R18006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.