"Lactobacillus Crispatus M247, LSIL and Microbiota"

Phase 4

Recruiting

• Conditions: Vaginal Flora Imbalance; ASC-US; LSIL; HPV Infection
• Interventions: Drug: Lactobacillus Crispatus M247

• Registration Number: NCT05808816
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-06-16
• Status Verified: 2023-02
• Primary Completion: 2023-02-02
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Pap smear ASCUS or L-SIL
• HPV test + (HPV-HR e/o HPV-LR)

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Exclusion Criteria

• Hormonal therapy (OC, ring, patch, implant)
• Pregnancy status
• Immunosuppressive therapies
• Ongoing HPV vaccination

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Lactobacillus Crispatus M247	Patient with oral supplementation of Lactobacillus Crispatus M247

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Cytological regression and microbiological clearance of HPV infection	5 months

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, RM, Italy