Clinical trial NCT06291350: Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid
Official title: Characterization of Peroodontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid: a Matched Controlled Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pemphigoid, Benign Mucous Membrane
Gingivitis Hyperplastic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases: 15 adult patients (over 18 years of age) with CP with erosive gingival expression (CP patients).

Control group 1: 15 adult patients (over 18 years of age) without CP, matched to cases on age, gender and periodontal conditions.

Control group 2: 15 adult patients (over 18 years of age) without CP, with healed periodontal conditions, matched to cases on age and gender.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: composition of the periodontal microbiota
timeFrame: at inclusion
Secondary outcomes:
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
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
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
city: Paris
country: France
facility: Paris hospital Pitié Salpetrière (APHP)
city: Paris
country: France
facility: Paris hospital Bretonneau (APHP)
Study officials:
References: