Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-08 @ 1:06 AM
Study NCT ID:
NCT04292067
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2020-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Faecal sampling at baseline for each subject'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-02-28', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacteria analysis', 'timeFrame': 'At the end of study, up to 4 years', 'description': 'Quantitative analysis of repartition of bacteria in each group and the comparison between groups.'}], 'secondaryOutcomes': [{'measure': 'Intestinal microbiota composition', 'timeFrame': 'At the end of study, up to 4 years', 'description': 'Intestinal microbiota composition will be analysed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spondyloarthritis', 'Rheumatoid Arthritis', 'Microbiota'], 'conditions': ['Spondyloarthritis', 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '28606969', 'type': 'BACKGROUND', 'citation': 'Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.', 'detailedDescription': 'As secondary objectives, the study aims to analyse the relation between different clinical parameters such as age, gender, duration of the disease, or the nature of ongoing treatment, and the the composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in SPA and/or RA. Analyse the relation between metabolome of faecale and plasma and the composition of intestinal microbiota.\n\nThis study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Adult patient diagnosed spondyloarthritis or rheumatoid polyarthritis;\n* Healthy adult subjects free of chronic pathology.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Patient ⩾ 18 years;\n* Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR/EULAR;\n* Affiliated to a social security scheme;\n* Have signed the written informed consent form.\n\nHealthy control subjects:\n\n* Adult women and men;\n* Subjet free of chronic pathology;\n* Affiliated to a social security scheme;\n* Have signed the written informed consent form.\n\nExclusion Criteria:\n\nPatients:\n\n* Patients unable to understand the proposed study and/or sign a informed consent form;\n* Pregnant women or breast feeding women;\n* Patient ⩾ 18 years;\n* Patients under guardianship or curatorship;\n* Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;\n* Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;\n* Foreign patients under french AME scheme;\n* Patients had have participated in the prior study Microbiart.\n\nHealthy control subjects:\n\n* Subjects unable to understand the proposed study and/or sign a informed consent form;\n* Pregnant women or breast feeding women;\n* Subjects \\< 18 years;\n* Subjects under guardianship or curatorship;\n* Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;\n* Refusal of subjects to participate to the study;\n* Foreign patients under french AME scheme;\n* Subjects had have participated in the prior study Microbiart.'}, 'identificationModule': {'nctId': 'NCT04292067', 'acronym': 'MICROBIART', 'briefTitle': 'Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'APHP190991'}, 'secondaryIdInfos': [{'id': '2019-A02632-55', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with SPA', 'description': '100 SPA patients', 'interventionNames': ['Biological: Faecal sampling', 'Biological: Blood sampling']}, {'label': 'Healthy subjets', 'description': '200 healthy subjets in control group', 'interventionNames': ['Biological: Faecal sampling', 'Biological: Blood sampling']}, {'label': 'patients with RA', 'description': '100 RA patients', 'interventionNames': ['Biological: Faecal sampling', 'Biological: Blood sampling']}], 'interventions': [{'name': 'Faecal sampling', 'type': 'BIOLOGICAL', 'description': 'Faecal sampling at baseline', 'armGroupLabels': ['Healthy subjets', 'patients with RA', 'patients with SPA']}, {'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': 'Blood sampling at baseline', 'armGroupLabels': ['Healthy subjets', 'patients with RA', 'patients with SPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime BREBAN, MD, PhD', 'role': 'CONTACT', 'email': 'maxime.breban@aphp.fr', 'phone': '+33 1 49 09 56 72'}], 'facility': 'Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}], 'centralContacts': [{'name': 'Maxime BREBAN, MD, PhD', 'role': 'CONTACT', 'email': 'maxime.breban@aphp.fr', 'phone': '+ 33 1 49 09 56 72'}], 'overallOfficials': [{'name': 'Maxime BREBAN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Rhumatologie, Hôpital Ambroise Paré, APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}