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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal transplant | Experimental | A single dose fecal transplant is given (via colonoscopy) from a healthy donor |
|
| Placebo | Placebo Comparator | A single dose patient's own feces is given (via colonoscopy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faecal transplantation | Procedure | Faecal transplantation from a healthy donor via colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 1 months after the procedure |
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Inclusion Criteria:
-Chronic Fatigue Syndrome
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tapani Salonen, MD, PhD | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | 33520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37516837 | Derived | 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. |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D003141 | Communicable Diseases |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Double-blinded study, treatment group and placebo-group
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Blinded products, investigators and patients are blinded. Fecal transplant is either from a healthy donor or patient's own feces
| Placebo faecal transplantation | Procedure | Placebo faecal transplantation containing patient's own feces via colonoscopy |
|
| 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 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) | 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) | 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) | Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D012816 | Signs and Symptoms |