"Lactobacillus Crispatus M247, LSIL and Microbiota"

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Enrolling; Phase 4

Conditions: LSIL; HPV Infection; ASC-US; Vaginal Flora Imbalance

Treatments: Drug: Lactobacillus Crispatus M247

Study type: Interventional

Funder types: Other

Identifiers

NCT05808816

ID 4010

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

Arm A

Experimental group

Description:

Patient with oral supplementation of Lactobacillus Crispatus M247

Treatment:

Drug: Lactobacillus Crispatus M247

Arm B

No Intervention group

Description:

Patients without oral supplementation of Lactobacillus Crispatus M247