ASC-US, HPV Infection, LSIL, Vaginal Flora Imbalance
Conditions
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
Interventions
Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota | 24 months |
Countries
Italy
Contacts
Primary ContactRosa Pasqualina RP De Vincenzo, Phd
Outcome results
None listed