Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-04 @ 8:58 PM
Study NCT ID:
NCT04687150
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2020-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'e'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-12-26', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified gut microbiota composition', 'timeFrame': 'at week 12', 'description': 'Increased species richness and alfa-diversity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years\n* Active newly diagnosed colitis (Mayo score \\<11)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Fulminant severe colitis (Mayo score 11-12 or Truelove and Witts criteria)\n* Gastrointestinal infection\n* Pregnancy\n* Antibiotic therapy at the baseline\n* On-going probiotic medication\n* Unable to provide signed informed consent'}, 'identificationModule': {'nctId': 'NCT04687150', 'acronym': 'FinUC', 'briefTitle': 'Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients', 'orgStudyIdInfo': {'id': 'T298/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The study group', 'description': 'The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit', 'interventionNames': ['Other: Fecal microbiota transplantation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The control group', 'description': 'The control group will be given colored water at same timepoints', 'interventionNames': ['Other: Colored water']}], 'interventions': [{'name': 'Fecal microbiota transplantation', 'type': 'OTHER', 'description': 'Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank', 'armGroupLabels': ['The study group']}, {'name': 'Colored water', 'type': 'OTHER', 'description': 'Colored water (placebo)', 'armGroupLabels': ['The control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Kimmo K Salminen, MD, PhD', 'role': 'CONTACT', 'email': 'kimmo.salminen@tyks.fi', 'phone': '+35823130691'}, {'name': 'Jaakko Rautakorpi, MD', 'role': 'CONTACT', 'email': 'jaakko.rautakorpi@tyks.fi', 'phone': '+35823138027'}], 'facility': 'Kimmo Salminen', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Kimmo K Salminen, MD, PhD', 'role': 'CONTACT', 'email': 'kimmo.salminen@tyks.fi', 'phone': '+35823130691'}, {'name': 'Jaakko Rautakorpi, MD', 'role': 'CONTACT', 'email': 'jaakko.rautakorpi@tyks.fi', 'phone': '+358238027'}], 'overallOfficials': [{'name': 'Kimmo K Salminen, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the section'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Päijänne Tavastia Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Specialist in Gastroenterology', 'investigatorFullName': 'Kimmo Salminen', 'investigatorAffiliation': 'Turku University Hospital'}}}}