"Lactobacillus Crispatus M247, LSIL and Microbiota"

NCT ID: NCT05808816

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2023-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Vaginal Flora Imbalance ASC-US LSIL HPV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Patient with oral supplementation of Lactobacillus Crispatus M247

Group Type EXPERIMENTAL

Lactobacillus Crispatus M247

Intervention Type DRUG

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

Arm B

Patients without oral supplementation of Lactobacillus Crispatus M247

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lactobacillus Crispatus M247

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Rosa Pasqualina RP De Vincenzo, Phd

Role: CONTACT

+0039 3393660390

Facility Contacts

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Rosa Pasqualina RP De Vincenzo, PhD

Role: primary

+39 3393660390

Other Identifiers

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ID 4010

Identifier Type: -

Identifier Source: org_study_id

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