Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid

NCT06291350 | Recruiting

• 1 other identifier: 23-AOI-05
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Pemphigoid, Benign Mucous Membrane; Gingivitis Hyperplastic

Outcome Measures

Primary Outcomes (1)

• composition of the periodontal microbiota

  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) Identification and quantification of bacterial populations in the subgingival plaque of cases and controls: global shotgun metagenomic approach, genetic sequencing on a third-generation sequencer

  at inclusion

Secondary Outcomes (4)

• Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3).

  at inclusion

• Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3).

  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)

  at inclusion

• Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3)

  at inclusion

Study Arms (3)

MMPg and periodontitis

15 adult patients with MMPg and periodontitis

Other: Plaque sampling and stool collection; Other: periodontal examination

no MMPg and periodontitis

15 adult patients not suffering from MMPg with periodontitis

Other: Plaque sampling and stool collection; Other: periodontal examination

no MMPg with healthy periodontal conditions

15 adult patients not suffering from MMPg with healthy periodontal conditions

Other: Plaque sampling and stool collection; Other: periodontal examination

Interventions

Plaque sampling and stool collection OTHER

Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis

MMPg and periodontitis; no MMPg and periodontitis; no MMPg with healthy periodontal conditions

periodontal examination OTHER

Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis

MMPg and periodontitis; no MMPg and periodontitis; no MMPg with healthy periodontal conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

Nice University Hospital

Nice, 06000, France

RECRUITING

Paris hospital Pitié Salpetrière (APHP)

Paris, 75013, France

RECRUITING

Paris hospital Bretonneau (APHP)

Paris, 75018, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plaque and stool collection

MeSH Terms

Conditions

Pemphigoid, Benign Mucous Membrane

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sophie DRIDI, PUPH

CONTACT

04 92 03 30 07; dr.sm.dridi@free.fr

rachida YATIMI

CONTACT

04 92 03 30 07; yatimi.r@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)