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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients

NCT06199128

Human Papillomavirus Infection

COMPLETED

Carrageenan-Containing Gel in Reducing the Rate of HPV Infection in Healthy Participants

NCT02382419

Healthy Subject Human Papillomavirus Infection

WITHDRAWN PHASE2

Evaluation Of The Efficacy Of The Combination Of GLIZIGEN® Oral Solution 1/Day And Vaginal Gel 1/Night For 2 Months In Patients With Cervical Intraepithelial Neoplasia Grade 1 (LSIL/CIN-1) Caused By High-Risk Human Papillomavirus (HPV-AR)

NCT05916911

Papilloma Viral Infection CIN1 LSIL, Low Grade Squamous Intraepithelial Lesion

RECRUITING PHASE4

Zinc Sulfate for Human Papillomavirus (HPV)

NCT03404310

Human Papilloma Virus

TERMINATED NA

A New Supplement for the Immune Response to HPV Infection

NCT02263378

HPV Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Human Papillomavirus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental, multicenter, randomized, placebo-cntrolled, longitudinal, prospective, single-blind, parallel-group study.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single-blind design (participants unaware of their group allocation).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic supplement Lactobacillus crispatus M247 group

Participants in this group will receive probiotic supplement Lactobacillus crispatus M247 (Crispact®) in stick form, administered orally at a dose of one stick per day for 4 months. Each stick contains 20 billion CFU of L. crispatus M247.

Group Type EXPERIMENTAL

Lactobacillus crispatus M247 (Crispact®)

Intervention Type DIETARY_SUPPLEMENT

Crispact® is a probiotic food supplement containing Lactobacillus crispatus M247.

Control Group

Participants in the control group will receive a placebo identical in appearance and packaging to the experimental product, administered orally at a dose of one stick per day for 4 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The placebo does not contain the active probiotic strain and consists of inactive excipients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus crispatus M247 (Crispact®)

Crispact® is a probiotic food supplement containing Lactobacillus crispatus M247.

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo does not contain the active probiotic strain and consists of inactive excipients.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No