"Lactobacillus Crispatus M247, LSIL and Microbiota"

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Criteria

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