Efficacy of Probiotic Lactobacillus Crispatus M247 in Promoting High-risk Human Papillomavirus (HR-HPV) Infection Clearance and Modifying Vaginal Microbiota

Evaluation of the Efficacy of Lactobacillus Crispatus M247 Administration in Promoting Clearance of Genital HR-HPV Infection and Modulating the Vaginal Microbiota: A Multicenter, Randomized, Placebo-Controlled, Single-Blind, Longitudinal, Prospective Clinical Trial

This clinical trial evaluates the efficacy of the probiotic strain Lactobacillus crispatus M247 in promoting the clearance of genital high-risk human papillomavirus (HR-HPV) infection and restoring the balance of the vaginal microbiota. The study adopts a multicenter, randomized, single-blind, longitudinal, prospective design involving HR-HPV-positive patients. Primary outcomes include HR-HPV clearance rates and microbiota composition changes.

This study investigates the potential benefits of Lactobacillus crispatus M247, a probiotic strain with proven ability to promote vaginal health, in the management of HR-HPV infections. Lactobacillus crispatus M247 has demonstrated superior probiotic properties, including the ability to produce lactic acid and hydrogen peroxide, which contribute to maintaining a stable vaginal microbiota and potentially inhibiting HR-HPV persistence.

Participants will be randomized to receive either Lactobacillus crispatus M247 or a placebo over a specified study period. The primary aim is to evaluate the probiotic's efficacy in enhancing HR-HPV clearance rates and restoring a balanced vaginal microbiota. Secondary objectives include assessing changes in cervical cytology and participant-reported outcomes on vaginal health. By focusing exclusively on the role of Lactobacillus crispatus M247, the study seeks to establish its clinical relevance in HR-HPV management and its potential as a therapeutic intervention.

Inclusion Criteria:

• Women aged 18-69 years.
• First diagnosis of HR-HPV infection via DNA-HPV screening.
• Cytology results showing ASC-US or LSIL.
• Negative colposcopy or biopsy (absence of lesions).
• Ability to provide written informed consent.

Exclusion Criteria:

• Prior HPV vaccination.
• History of cervical treatments for pre-neoplastic pathology.
• Cytology showing HSIL (High-Grade Squamous Intraepithelial Lesion) requiring treatment.
• Current treatment with antibiotics, immunomodulatory, or immunosuppressive therapies.
• Diagnosed immune system or neoplastic diseases requiring chemotherapy.
• Pregnancy, lactation, or planning to become pregnant within 6 months.
• Known hypersensitivity to product components.