Clinical trial NCT06802809: Efficacy of Probiotic Lactobacillus Crispatus M247 in Promoting High-risk Human Papillomavirus (HR-HPV) Infection Clearance and Modifying Vaginal Microbiota
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Infection
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2025-01-31
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, multicenter, randomized, placebo-cntrolled, longitudinal, prospective, single-blind, parallel-group study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HR-HPV Clearance Rate
timeFrame: Baseline to 4 months post-intervention
Secondary outcomes:
measure: Modifications in Vaginal Microbiota
timeFrame: Baseline to 4 months post-intervention.
measure: Microbiota Characteristics Favoring HR-HPV Infection or Clearance
timeFrame: Baseline to 4 months post-intervention.
measure: Cervical Cytology Normalization
timeFrame: Baseline to 4 months post-intervention.
measure: Number of patients reporting side effects to probiotic Crispact® intake
timeFrame: From baseline to 4 months post-intervention.
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco"
city: Lentini
country: Italy
facility: Nuovo Ospedale di Lentini
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo
Study officials:
References: