Fatigue Syndrome, ChronicNCT04158427
Intestinal Microbiota and Chronic Fatigue Syndrome
A study testing Faecal transplantation in people with Fatigue Syndrome, Chronic and Microbial Colonization, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue Syndrome, Chronic, Microbial Colonization
- What is being tested?
- Faecal transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Chronic Fatigue Syndrome
Who cannot join
- Other conditions causing chronic fatigue
- Diseases affecting the intestinal system
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the detailed 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).
- Conditions
- Fatigue Syndrome, Chronic, Microbial Colonization
- Being tested
- Faecal transplantation, Placebo faecal transplantation
- Keywords
- fatigue, microbiome
- Medical subject headings
- Fatigue Syndrome, Chronic, Communicable Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal transplantationProcedure or surgery
Faecal transplantation from a healthy donor via colonoscopy
Placebo faecal transplantationProcedure or surgery
Placebo faecal transplantation containing patient's own feces via colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Fecal transplant | Experimental | A single dose fecal transplant is given (via colonoscopy) from a healthy donor Receives: Procedure: Faecal transplantation |
| Placebo | Placebo comparator | A single dose patient's own feces is given (via colonoscopy) Receives: Procedure: Placebo faecal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
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)
Measured: Change from Baseline EQ-5D-5L scores at 1 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)
Measured: Change from Baseline 15D at 1 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)
Measured: Change from Baseline Modified Fatigue Impact Scale scores at 1 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)
Measured: Change from Baseline at 1 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)
Measured: Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded study, treatment group and placebo-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Tapani Salonen, Tampere University Hospital
- Investigators
- Tapani Salonen, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158427
- Sponsor's protocol ID
- R18006
- Status last verified
- Apr 2022
- First submitted
- 8 Aug 2019
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37516837
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04158427
- Acronym / sponsor ID
- R18006
- Conditions
- Fatigue Syndrome, Chronic, Microbial Colonization
- Keywords
- fatigue, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded study, treatment group and placebo-group
| Arm | Type | Receives |
|---|---|---|
| Fecal transplant | Experimental | Procedure: Faecal transplantationA single dose fecal transplant is given (via colonoscopy) from a healthy donor |
| Placebo | Placebo comparator | Procedure: Placebo faecal transplantationA single dose patient's own feces is given (via colonoscopy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Chronic Fatigue Syndrome
Key exclusion criteria (2 listed)
- Other conditions causing chronic fatigue
- Diseases affecting the intestinal system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faecal transplantationFaecal transplantation from a healthy donor via colonoscopy | Procedure or surgery | Fecal transplant |
| Placebo faecal transplantationPlacebo faecal transplantation containing patient's own feces via colonoscopy | Procedure or surgery | Placebo |
Primary outcome
Health related quality of life assessed by EQ-5D-5L questionnaire
Time frame: Change from Baseline EQ-5D-5L scores at 6 months after the procedure
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)
Health related quality of life assessed by 15D questionnaire
Time frame: Change from Baseline 15D scores at 6 months after the procedure
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)
Health related quality of life assessed by Modified Fatigue Impact Scale
Time frame: Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure
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)
Ability to work or study
Time frame: Change from Baseline at 6 months after the procedure
Whether ability to work or study has been restored (value is 1) or not (value is 0)
Visual Analog Fatigue Scale
Time frame: Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure
A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)
5 secondary outcomes
Health related quality of life assessed by EQ-5D-5L questionnaire
Time frame: Change from Baseline EQ-5D-5L scores at 1 months after the procedure
Health related quality of life assessed by 15D questionnaire
Time frame: Change from Baseline 15D at 1 months after the procedure
Health related quality of life assessed by Modified Fatigue Impact Scale
Time frame: Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure
Ability to work or study
Time frame: Change from Baseline at 1 months after the procedure
Visual Analog Fatigue Scale
Time frame: Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Derived from this study: PubMed 37516837Salonen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tapani Salonen, MD, PhD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal transplantation in people with Fatigue Syndrome, Chronic and Microbial Colonization, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life assessed by EQ-5D-5L questionnaire (time frame: Change from Baseline EQ-5D-5L scores at 6 months after the procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04158427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.