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Development of a visualized diagnostic method for pathogen-immune interactions based on vaginal microbiota

Based on multiplex PCR and flow cytometry: construction of vaginal pathogen-host immune interaction atlas and development of an auxiliary diagnostic model

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128993
Enrollment
Unknown
Registered
2026-07-29
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Vaginitis ?Cervicitis?Abnormal vaginal discharge?HPV infection?Cervical lesion

Interventions

HPV-positive patients:None
Patients with vaginitis:None

Sponsors

Shandong Provincial Hospital (Shandong Provincial Children's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: 1. Female, aged 18–49 years (post-menarche and >=1 year prior to menopause); 2. Non-pregnant (negative urine hCG within 7 days); 3. Voluntarily signed written informed consent; 4. Agreed to complete 12-month follow-up via telephone and outpatient visits; 5. Sexually active history (>=1 episode of vaginal intercourse); 6. No use of antibiotics, probiotics, vaginal douching, or hormonal gel within the past 6 months.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation; 2. History of cervical surgical treatment within the recent period; 3. Pelvic radiotherapy or chemotherapy within the past 6 months; 4. Immunosuppressive therapy (prednisone >20 mg·day?^1 for >14 days, biologics, or anti-rejection medications for transplant); 5. Acute vulvovaginal candidiasis requiring systemic antifungal therapy (topical treatment 3 days within the past 6 weeks; 8. Unable to complete follow-up (planned relocation, severe psychiatric illness); 9. Acute inflammatory phase of the reproductive tract.

Design outcomes

Primary

MeasureTime frame
Immune phenotyping;Microbiota detection;Follow-up outcomes;

Secondary

MeasureTime frame
Clinical parameters;Inflammatory cytokines;

Countries

China

Contacts

Public ContactWang Fei

Shandong Provincial Hospital (Shandong Provincial Children's Hospital)

15168863608@163.com+86 531 68776380

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026