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Trial Title:
"Lactobacillus Crispatus M247, LSIL and Microbiota"
NCT ID:
NCT05808816
Condition:
Vaginal Flora Imbalance
ASC-US
LSIL
HPV Infection
Conditions: Official terms:
Papillomavirus Infections
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lactobacillus Crispatus M247
Description:
Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade
lesions HPV related
Arm group label:
Arm A
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
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rosa Pasqualina RP De Vincenzo, PhD
Phone:
+39 3393660390
Email:
rosapasqualina.devincenzo@policlinicogemelli.it
Start date:
June 16, 2021
Completion date:
June 30, 2023
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05808816
