NCT06802809

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus crispatus M247 (Crispact®)	Crispact® is a probiotic food supplement containing Lactobacillus crispatus M247.
OTHER	Placebo	The placebo does not contain the active probiotic strain and consists of inactive excipients.

Timeline

• Start date: 2022-01-05
• Primary completion: 2024-11-30
• Completion: 2024-12-30
• First posted: 2025-01-31
• Last updated: 2025-06-04

Locations

3 sites across 1 country: Italy