Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 4:55 AM
Study NCT ID:
NCT06291350
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010390', 'term': 'Pemphigoid, Benign Mucous Membrane'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plaque and stool collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composition of the periodontal microbiota', 'timeFrame': 'at inclusion', 'description': 'Compare the composition (name and number of bacterial colonies) of the periodontal microbiota between patients with MMPg and periodontitis (cases) and control patients (non-MMPg with case-matched periodontitis or non-MMPg with healthy periodontium)\n\nIdentification and quantification of bacterial populations in the subgingival plaque of cases and controls: global shotgun metagenomic approach, genetic sequencing on a third-generation sequencer'}], 'secondaryOutcomes': [{'measure': 'Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3).', 'timeFrame': 'at inclusion'}, {'measure': 'Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3).', 'timeFrame': 'at inclusion', 'description': "stool sampling at the patient's home after inclusion"}, {'measure': 'Compare (name and number of bacterial colonies) periodontal microbiota composition in MMP and control patients (arm 2) according to periodontitis severity (non-severe/severe)', 'timeFrame': 'at inclusion'}, {'measure': 'Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3)', 'timeFrame': 'at inclusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pemphigoid, Benign Mucous Membrane', 'Gingivitis Hyperplastic']}, 'descriptionModule': {'briefSummary': 'Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa.\n\nIndeed, the dysbiotic periodontal microbiota could aggravate the gingival damage specific to MMP, either directly by activating inflammatory pathways, or indirectly by degrading cellular and matrix components. On the other hand, areas of erosive gingiva generated by the autoimmune process could increase the virulent power of periodontal pathobionts, by representing accessible, nutrient-rich connective surfaces. Moreover, in recent years, bacterial studies based on a high-throughput metagenomic approach have suggested the existence of a relationship between the oral and intestinal microbiota in patients with degraded periodontal conditions and suffering from autoimmune inflammatory diseases (inflammatory bowel disease, acute graft-versus-host disease). This relationship can also be envisaged in MMPg patients who meet the conditions that allow this type of pathological process to occur: autoimmune disease; disruption of the gingival epithelial barrier in erosive gingival areas (increasing the risk of antigen exposure); large amounts of thick plaque; degraded periodontal condition with the presence of numerous periodontal pockets from which periodontopathogenic bacteria can translocate intra-tissularly and cause distant adverse consequences.\n\nThe main aim of this observational, multicentre, case-control, matched study is to compare the composition of the periodontal microbiota between MMPg patients and control patients (arm 2 and arm 3). The secondary objectives are to compare the composition of periodontal and intestinal microbiota in cases and control patients (arm 2 and arm 3), to compare periodontal microbiota composition in cases and control patients (arm 2) according to periodontitis severity, and to compare gut microbiota composition between cases and control patients (arm 2 and arm3). To date, no such study exists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cases: 15 adult patients (over 18 years of age) with CP with erosive gingival expression (CP patients).\n\nControl group 1: 15 adult patients (over 18 years of age) without CP, matched to cases on age, gender and periodontal conditions.\n\nControl group 2: 15 adult patients (over 18 years of age) without CP, with healed periodontal conditions, matched to cases on age and gender.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults (over 18), non-smokers Arm 1\n\n* MMPg (initial, persistent despite medical treatment, recurrent), periodontitis Arm 2\n* non-MMPg, periodontitis, matched to cases on age, gender and severity of periodontitis\n\nArm 3:\n\n\\- non-MMPg, healthy periodontal conditions, matched to cases on age and gender\n\nExclusion Criteria:\n\n* Antibiotic therapy and mechanical periodontal treatment within 3 months prior to study, other chronic general illness of immune or digestive origin'}, 'identificationModule': {'nctId': 'NCT06291350', 'acronym': 'MICROPC', 'briefTitle': 'Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Characterization of Peroodontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid: a Matched Controlled Study', 'orgStudyIdInfo': {'id': '23-AOI-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MMPg and periodontitis', 'description': '15 adult patients with MMPg and periodontitis', 'interventionNames': ['Other: Plaque sampling and stool collection', 'Other: periodontal examination']}, {'label': 'no MMPg and periodontitis', 'description': '15 adult patients not suffering from MMPg with periodontitis', 'interventionNames': ['Other: Plaque sampling and stool collection', 'Other: periodontal examination']}, {'label': 'no MMPg with healthy periodontal conditions', 'description': '15 adult patients not suffering from MMPg with healthy periodontal conditions', 'interventionNames': ['Other: Plaque sampling and stool collection', 'Other: periodontal examination']}], 'interventions': [{'name': 'Plaque sampling and stool collection', 'type': 'OTHER', 'description': 'Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis', 'armGroupLabels': ['MMPg and periodontitis', 'no MMPg and periodontitis', 'no MMPg with healthy periodontal conditions']}, {'name': 'periodontal examination', 'type': 'OTHER', 'description': 'Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis', 'armGroupLabels': ['MMPg and periodontitis', 'no MMPg and periodontitis', 'no MMPg with healthy periodontal conditions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie DRIDI, PUPH', 'role': 'CONTACT', 'email': 'dr.sm.dridi@free.fr', 'phone': '04 92 03 30 07'}, {'name': 'Rachida Yatimi', 'role': 'CONTACT', 'email': 'yatimi.r@chu-nice.fr', 'phone': '04 92 03 30 07'}, {'name': 'Sophie DRIDI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Juliette ROCHEFORT', 'role': 'CONTACT', 'email': 'juliette.rochefort@aphp.fr', 'phone': '0142178416'}, {'name': 'Juliette ROCHEFORT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Paris hospital Pitié Salpetrière (APHP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Laure EJEIL', 'role': 'CONTACT', 'email': 'anne-laure.ejeil@aphp.fr', 'phone': '0153111800'}, {'name': 'Anne-Laure AJEIL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Paris hospital Bretonneau (APHP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Sophie DRIDI, PUPH', 'role': 'CONTACT', 'email': 'dr.sm.dridi@free.fr', 'phone': '04 92 03 30 07'}, {'name': 'rachida YATIMI', 'role': 'CONTACT', 'email': 'yatimi.r@chu-nice.fr', 'phone': '04 92 03 30 07'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}