NCT05808816

"Lactobacillus Crispatus M247, LSIL and Microbiota"

Interventional Study on Efficacy of Lactobacillus Crispatus M247 in Patients Affected by HPV Low-grade Preneoplastic Cervical Lesions and Evaluation of Vaginal Microbiota Changes Before and After Oral Supplementation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Vaginal Flora Imbalance
• ASC-US
• LSIL
• HPV Infection

Interventions

Type	Name	Description
DRUG	Lactobacillus Crispatus M247	Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related

Timeline

• Start date: 2021-06-16
• Primary completion: 2023-02-02
• Completion: 2023-06-30
• First posted: 2023-04-11
• Last updated: 2023-04-11

Locations

1 site across 1 country: Italy