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

NCT06802809 | Completed DMC

• 1 other identifier: Protocol n° 774/18.10.2021/AK
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• HR-HPV Clearance Rate

  Percentage of participants in whom HR-HPV infection is no longer detectable, as assessed by an HPV-DNA test.

  Baseline to 4 months post-intervention

Secondary Outcomes (4)

• Modifications in Vaginal Microbiota

  Baseline to 4 months post-intervention.

• Microbiota Characteristics Favoring HR-HPV Infection or Clearance

  Baseline to 4 months post-intervention.

• Cervical Cytology Normalization

  Baseline to 4 months post-intervention.

• Number of patients reporting side effects to probiotic Crispact® intake

  From baseline to 4 months post-intervention.

Study Arms (2)

Probiotic supplement Lactobacillus crispatus M247 group

EXPERIMENTAL

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.

Dietary Supplement: Lactobacillus crispatus M247 (Crispact®)

Control Group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Lactobacillus crispatus M247 (Crispact®) DIETARY_SUPPLEMENT

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

Probiotic supplement Lactobacillus crispatus M247 group

Placebo OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: This study includes individuals who self-identify as female and meet the inclusion criteria, as the study focuses on conditions affecting the female reproductive system (e.g., HR-HPV infections and vaginal microbiota.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Università degli Studi dell'Insubria: collaborator

Study Sites (3)

Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco"

Catania, 95121, Italy

Location

Nuovo Ospedale di Lentini

Lentini, 96016, Italy

Location

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind design (participants unaware of their group allocation).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

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

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: January 31, 2025
• Study Start: January 5, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)