Human Papillomavirus Infection
Conditions
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.
Interventions
OTHERPlacebo
The placebo does not contain the active probiotic strain and consists of inactive excipients.
DIETARY_SUPPLEMENTLactobacillus crispatus M247 (Crispact®)
Crispact® is a probiotic food supplement containing Lactobacillus crispatus M247.
Sponsors
Università degli Studi dell'Insubria
Liaquat University of Medical & Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single-blind design (participants unaware of their group allocation).
Intervention model description
Experimental, multicenter, randomized, placebo-cntrolled, longitudinal, prospective, single-blind, parallel-group study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed