Lactobacillus Crispatus M247, LSIL and Microbiota

Study Overview
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Brief Summary
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Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m

Official Title
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Interventional Study on Efficacy of Lactobacillus Crispatus M247 in Patients Affected by HPV Low-grade Preneoplastic Cervical Lesions and Evaluation of Vaginal Microbiota Changes Before and After Oral Supplementation

Conditions
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Vaginal Flora Imbalance, ASC-US, LSIL, HPV Infection

Intervention / Treatment
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* Drug: Lactobacillus Crispatus M247


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pap smear ASCUS or L-SIL HPV test + (HPV-HR e/o HPV-LR) Exclusion Criteria: Hormonal therapy (OC, ring, patch, implant) Pregnancy status Immunosuppressive therapies Ongoing HPV vaccination

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Patient with oral supplementation of Lactobacillus Crispatus M247 | Drug: Lactobacillus Crispatus M247<br>* Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related<br>|
| No Intervention: Arm B<br>Patients without oral supplementation of Lactobacillus Crispatus M247 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of Lactobacillus Crispatus M247 oral supplementation to change the genetic profile of the vaginal microbiota of patients with low-grade lesions from HPV, by XBIOGem test. |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytological regression and microbiological clearance of HPV infection |  | 5 months | 
| Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient |  | 24 months | 
| Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota |  | 24 months |