"Lactobacillus Crispatus M247, LSIL and Microbiota"

March 29, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Patient with oral supplementation of Lactobacillus Crispatus M247
Drug: Lactobacillus Crispatus M247
Oral supplementation of Lactobacillus Crispatus M247 in patients with cervical low grade lesions HPV related
No Intervention: Arm B
Patients without oral supplementation of Lactobacillus Crispatus M247

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cytological regression and microbiological clearance of HPV infection
Time Frame: 5 months
5 months
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
24 months
Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Actual)

February 2, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 4010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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