Back to results"Lactobacillus Crispatus M247, LSIL and Microbiota"
Primary Purpose
Vaginal Flora Imbalance, ASC-US, LSIL
Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus Crispatus M247
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Flora Imbalance
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
Sites / Locations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm A
Arm B
Arm Description
Patient with oral supplementation of Lactobacillus Crispatus M247
Patients without oral supplementation of Lactobacillus Crispatus M247
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cytological regression and microbiological clearance of HPV infection
Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient
Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota
Full Information
NCT ID
NCT05808816
First Posted
March 29, 2023
Last Updated
March 29, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05808816
Brief Title
"Lactobacillus Crispatus M247, LSIL and Microbiota"
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Flora Imbalance, ASC-US, LSIL, HPV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Patient with oral supplementation of Lactobacillus Crispatus M247
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
Patients without oral supplementation of Lactobacillus Crispatus M247
Intervention Type
Drug
Intervention Name(s)
Lactobacillus Crispatus M247
Intervention Description
Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related
Primary Outcome Measure Information:
Title
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Cytological regression and microbiological clearance of HPV infection
Time Frame
5 months
Title
Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient
Time Frame
24 months
Title
Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota
Time Frame
24 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa Pasqualina RP De Vincenzo, Phd
Phone
+0039 3393660390
Email
rosapasqualina.devincenzo@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Pasqualina RP De Vincenzo, PhD
Phone
+39 3393660390
Email
rosapasqualina.devincenzo@policlinicogemelli.it
12. IPD Sharing Statement
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"Lactobacillus Crispatus M247, LSIL and Microbiota"
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