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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patient with oral supplementation of Lactobacillus Crispatus M247 |
|
| Arm B | No Intervention | Patients without oral supplementation of Lactobacillus Crispatus M247 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Crispatus M247 | Drug | Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosa Pasqualina RP De Vincenzo, Phd | Contact | +0039 3393660390 | rosapasqualina.devincenzo@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | RM | 00168 | Italy |
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| ID | Term |
|---|---|
| D065309 | Atypical Squamous Cells of the Cervix |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
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| Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota | 24 months |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |