"Lactobacillus Crispatus M247, LSIL and Microbiota"

Last updated: March 29, 2023
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

4

Condition

Vaginal Infection

Treatment

N/A

Clinical Study ID

NCT05808816
ID 4010
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 90
Study Start date:
June 16, 2021
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM 00168
    Italy

    Active - Recruiting

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