"Lactobacillus Crispatus M247, LSIL and Microbiota"
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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