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

Not Applicable

Completed

• Conditions: Human Papillomavirus Infection

• Registration Number: NCT06802809
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief 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.

Study Timeline

• Study Start: 2022-07-05
• Primary Completion: 2024-01-31
• Study Completion: 2024-09-30
• Study First Submitted: 2025-01-25
• Study First Submitted QC: 2025-01-25
• Study First Posted: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HR-HPV Clearance Rate	Baseline to 4 months post-intervention	Percentage of participants in whom HR-HPV infection is no longer detectable, as assessed by an HPV-DNA test.

Secondary Outcome Measures

Name	Time	Method
Modifications in Vaginal Microbiota	Baseline to 4 months post-intervention.	Changes in the composition of the vaginal microbiota, including the abundance of Lactobacillus species (especially Lactobacillus crispatus) and microbiota diversity indices, as assessed by Next-Generation Sequencing of the 16S ribosomal RNA gene (NGS 16S) sequencing.
Microbiota Characteristics Favoring HR-HPV Infection or Clearance	Baseline to 4 months post-intervention.	Identification of vaginal microbiota profiles (e.g., CST-I (Community State Type-I) to CST-IV (Community State Type-IV) distribution) associated with HR-HPV persistence or clearance, as determined by NGS 16S sequencing
Cervical Cytology Normalization	Baseline to 4 months post-intervention.	Proportion of participants with normalization of cervical cytology results, transitioning from ASC-US (Atypical Squamous Cells of Undetermined Significance) or LSIL (Low-Grade Squamous Intraepithelial Lesion) to normal cytology, as determined by Papanicolaou (Pap) test analysis.
Number of patients reporting side effects to probiotic Crispact® intake	From baseline to 4 months post-intervention.	Number and type of adverse events reported, including gastrointestinal symptoms, allergic reactions, or other health concerns, as recorded in participant safety logs.

Trial Locations

Locations (3)

Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco"; 🇮🇹 Catania, Italy

Nuovo Ospedale di Lentini; 🇮🇹 Lentini, Italy

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo; 🇮🇹 Palermo, Italy