Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT04158427
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intestinal Microbiota and Chronic Fatigue Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Blinded products, investigators and patients are blinded. Fecal transplant is either from a healthy donor or patient's own feces"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded study, treatment group and placebo-group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health related quality of life assessed by EQ-5D-5L questionnaire', 'timeFrame': 'Change from Baseline EQ-5D-5L scores at 6 months after the procedure', 'description': '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)'}, {'measure': 'Health related quality of life assessed by 15D questionnaire', 'timeFrame': 'Change from Baseline 15D scores at 6 months after the procedure', 'description': '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)'}, {'measure': 'Health related quality of life assessed by Modified Fatigue Impact Scale', 'timeFrame': 'Change from Baseline Modified Fatigue Impact Scale scores at 6 months after the procedure', 'description': '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)'}, {'measure': 'Ability to work or study', 'timeFrame': 'Change from Baseline at 6 months after the procedure', 'description': 'Whether ability to work or study has been restored (value is 1) or not (value is 0)'}, {'measure': 'Visual Analog Fatigue Scale', 'timeFrame': 'Change from Baseline Visual Analog Fatigue Scale point at 6 months after the procedure', 'description': 'A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life assessed by EQ-5D-5L questionnaire', 'timeFrame': 'Change from Baseline EQ-5D-5L scores at 1 months after the procedure', 'description': '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)'}, {'measure': 'Health related quality of life assessed by 15D questionnaire', 'timeFrame': 'Change from Baseline 15D at 1 months after the procedure', 'description': '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)'}, {'measure': 'Health related quality of life assessed by Modified Fatigue Impact Scale', 'timeFrame': 'Change from Baseline Modified Fatigue Impact Scale scores at 1 months after the procedure', 'description': '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)'}, {'measure': 'Ability to work or study', 'timeFrame': 'Change from Baseline at 1 months after the procedure', 'description': 'Whether ability to work or study has been restored (value is 1) or not (value is 0)'}, {'measure': 'Visual Analog Fatigue Scale', 'timeFrame': 'Change from Baseline Visual Analog Fatigue Scale point at 1 months after the procedure', 'description': 'A 100 mm horizontal line with written descriptions at each end (0 = no fatigue; 100 = extreme fatigue)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fatigue', 'microbiome'], 'conditions': ['Fatigue Syndrome, Chronic', 'Microbial Colonization']}, 'referencesModule': {'references': [{'pmid': '37516837', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "Gut microbiota of 1) patients with chronic fatigue syndrome and 2) their healthy family members are analyzed.\n\nUp 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)", 'detailedDescription': "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.\n\nVia 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Chronic Fatigue Syndrome\n\nExclusion Criteria:\n\n* Other conditions causing chronic fatigue\n* Diseases affecting the intestinal system'}, 'identificationModule': {'nctId': 'NCT04158427', 'briefTitle': 'Intestinal Microbiota and Chronic Fatigue Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Intestinal Microbiota and Chronic Fatigue Syndrome. Effect of Fecal Transplant on Health Related Quality of Life of the Patients With Chronic Fatigue Syndrome', 'orgStudyIdInfo': {'id': 'R18006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fecal transplant', 'description': 'A single dose fecal transplant is given (via colonoscopy) from a healthy donor', 'interventionNames': ['Procedure: Faecal transplantation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "A single dose patient's own feces is given (via colonoscopy)", 'interventionNames': ['Procedure: Placebo faecal transplantation']}], 'interventions': [{'name': 'Faecal transplantation', 'type': 'PROCEDURE', 'description': 'Faecal transplantation from a healthy donor via colonoscopy', 'armGroupLabels': ['Fecal transplant']}, {'name': 'Placebo faecal transplantation', 'type': 'PROCEDURE', 'description': "Placebo faecal transplantation containing patient's own feces via colonoscopy", 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33520', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Tapani Salonen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, PhD', 'investigatorFullName': 'Tapani Salonen', 'investigatorAffiliation': 'Tampere University Hospital'}}}}