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Characterization of the salivary microbiota in patients with common bullous diseases of the oral mucosa

Characterization of the salivary microbiota in patients with common bullous diseases of the oral mucosa

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105460
Enrollment
Unknown
Registered
2025-07-03
Start date
2023-08-13
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous diseases of the oral mucosa

Interventions

Healthy control:None
Mucosal-dominant pemphigus vulgaris:None
Low-risk mucous membrane pemphigoid:None

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1: Case group: low-risk mucosal pemphigus (1) Clinical manifestations: blisters, erosion or diffuse erythema on the gums, and/or oral mucosal blisters or erosion, without skin, eye, pharynx, throat, esophagus, anus, and external genital mucosal lesions. (2) Direct immunofluorescence shows linear deposition of IgG and/or C3 in the epithelial basement membrane, accompanied by deposition of IgA and IgM. (3) Histopathology shows the formation of subepithelial blisters, with separation of the epithelial layer from the lamina propria. (4) ELISA detected the presence of anti BP180 antibodies in the serum. Those who meet at least (1)+(2) or (1)+(2)+(4) criteria can be diagnosed as low-risk mucosal pemphigus. 2: Case group: Mucosal dominant pemphigus vulgaris (1) Clinical manifestations: ? Oral mucosal blisters or erosion, without skin and other mucosal lesions in the body cavity? Ni's sign (+); ? After the blister ruptures, it forms stubborn erosion (2) Histopathology: Epidermal/intraepithelial blister formation (spinous layer lysis) (3) Immunodiagnostic indicators: ? Direct immunofluorescence shows a network deposition of IgG (or accompanied by C3) between spinous cells; ? ELISA detection shows positive results for anti Dsg3 antibodies (or accompanying anti Dsg1 antibodies). Diagnosis can be made by meeting at least one of the "clinical manifestations", at least one of the "tissue pathology", and "immune diagnostic indicators" At least 2 of the "clinical manifestations" and 2 of the "immune diagnostic indicators" can also be diagnosed as mucosal dominant pemphigus vulgaris. 3: Control group: Healthy adults without oral mucosal disease, periodontal disease, and caries

Exclusion criteria

Exclusion criteria: 1: Case group (low-risk mucous membrane pemphigoid and mucosa-dominant pemphigus vulgaris): (1) Pemphigus vulgaris and mucous membrane pemphigoid lesions involving oral mucosa and other body cavity mucosa and skin lesions at the same time; (2) Suffering from other oral mucosal diseases; (3) Those who have used local or systemic immunological preparations within 3 months, and those who have used antibiotics and/or hormones locally or systemically within 1 month. 2: Control group: (1) Individuals suffering from severe other systemic diseases (2) Individuals who have received local or systemic use of immune preparations within 3 months, and those who have received local or systemic use of antibiotics and/or glucocorticoids within 1 month.

Design outcomes

Primary

MeasureTime frame
Oral microbial composition;

Countries

China

Contacts

Public ContactXin Zeng

West China Hospital of Stomatology, Sichuan University

zengxin22@163.com+86 159 2808 0862

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026