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| Name | Class |
|---|---|
| Università degli Studi dell'Insubria | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus crispatus M247 (Crispact®) | Dietary Supplement | Crispact® is a probiotic food supplement containing Lactobacillus crispatus M247. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Modifications in Vaginal Microbiota | 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. | Baseline to 4 months post-intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco" | Catania | 95121 | Italy | |||
| Nuovo Ospedale di Lentini |
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Experimental, multicenter, randomized, placebo-cntrolled, longitudinal, prospective, single-blind, parallel-group study.
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Single-blind design (participants unaware of their group allocation).
| Placebo | Other | The placebo does not contain the active probiotic strain and consists of inactive excipients. |
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| Microbiota Characteristics Favoring HR-HPV Infection or Clearance | 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 | Baseline to 4 months post-intervention. |
| Cervical Cytology Normalization | 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. | Baseline to 4 months post-intervention. |
| Number of patients reporting side effects to probiotic Crispact® intake | Number and type of adverse events reported, including gastrointestinal symptoms, allergic reactions, or other health concerns, as recorded in participant safety logs. | From baseline to 4 months post-intervention. |
| Lentini |
| 96016 |
| Italy |
| Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo | Palermo | 90127 | Italy |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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