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Идёт набор NCT06291350

Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid

— Наблюдательное Pemphigoid, Benign Mucous Membrane Gingivitis Hyperplastic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Plaque sampling and stool collection, periodontal examination.
Кому может быть актуально
Состояния в реестре: Pemphigoid, Benign Mucous Membrane, Gingivitis Hyperplastic. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Characterization of Peroodontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid: a Matched Controlled Study

Обзор

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. Indeed, 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. The 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.

Вмешательства

  • Другое Plaque sampling and stool collection
    Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis
  • Другое periodontal examination
    Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis

Первичные конечные точки

  • composition of the periodontal microbiota [Срок оценки: at inclusion]
Вторичные конечные точки (4)
  • Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3). [Срок оценки: at inclusion]
  • Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3). [Срок оценки: at inclusion]
  • Compare (name and number of bacterial colonies) periodontal microbiota composition in MMP and control patients (arm 2) according to periodontitis severity (non-severe/severe) [Срок оценки: at inclusion]
  • Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3) [Срок оценки: at inclusion]

Критерии участия

Критерии включения

Adults (over 18), non-smokers Arm 1

  • MMPg (initial, persistent despite medical treatment, recurrent), periodontitis Arm 2
  • non-MMPg, periodontitis, matched to cases on age, gender and severity of periodontitis

Arm 3:

\- non-MMPg, healthy periodontal conditions, matched to cases on age and gender

Критерии исключения

  • Antibiotic therapy and mechanical periodontal treatment within 3 months prior to study, other chronic general illness of immune or digestive origin

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Франция · 3 центра
  • Nice University Hospital — Nice
  • Paris hospital Pitié Salpetrière (APHP) — Paris
  • Paris hospital Bretonneau (APHP) — Paris

Идентификаторы

NCT: NCT06291350 · 23-AOI-05

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗