"Lactobacillus Crispatus M247, LSIL and Microbiota"

HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808816
• Other study ID #: ID 4010
• Status: Recruiting
• Phase: Phase 4
• Start date: June 16, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Rosa Pasqualina RP De Vincenzo, Phd
• Phone: +0039 3393660390
• Email: rosapasqualina.devincenzo[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lactobacillus Crispatus M247
Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cytological regression and microbiological clearance of HPV infection		5 months
Secondary	Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient		24 months
Secondary	Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota		24 months