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NCT Number: NCT06802809

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

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.

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Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus crispatus M247 (Crispact®)

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. HR-HPV Clearance Rate

    Time frame: 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 outcomes

  1. Modifications in Vaginal Microbiota

    Time frame: 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.

  2. Microbiota Characteristics Favoring HR-HPV Infection or Clearance

    Time frame: 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

  3. Cervical Cytology Normalization

    Time frame: 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.

  4. Number of patients reporting side effects to probiotic Crispact® intake

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • Università degli Studi dell'Insubria

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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