Evaluation of the Efficacy and Safety of Lactobacillus Crispatus M247 (Crispact®) With Vaginal Laser Therapy in Menopausal Women With Atrophic Vulvovaginitis (VVA)

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

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-12-09

Brief Summary

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This randomized, controlled, prospective, multicenter study aims to evaluate the efficacy and safety of Lactobacillus crispatus M247 in combination with vaginal laser therapy for improving vaginal microbiota composition and reducing genitourinary symptoms in menopausal women with atrophic vulvovaginitis (VVA). Participants will be randomized into two groups: one receiving laser therapy alone and the other receiving laser therapy combined with daily administration of the probiotic Lactobacillus crispatus M247 (Crispact®). Primary outcomes include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety. Secondary outcomes include changes in vaginal microbiota composition.

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Detailed Description

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Atrophic vulvovaginitis (VVA) is a common condition affecting menopausal women, characterized by symptoms such as vaginal dryness, dyspareunia, itching, and recurrent urinary tract infections. These symptoms result from decreased estrogen levels leading to an imbalance in vaginal microbiota. Standard treatments for VVA include hormonal therapy, but this approach is often associated with adverse effects and contraindications.

This study investigates a non-hormonal approach using Lactobacillus crispatus M247 (Crispact®), a probiotic strain known for its ability to maintain a healthy vaginal microbiota, in combination with vaginal laser therapy. The study will include 75 menopausal women diagnosed with VVA who will be randomized in a 2:1 ratio, with a greater proportion allocated to the laser-only group and the remaining participants receiving laser therapy combined with the probiotic.

Primary outcomes will include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety over the study period. Secondary outcomes will include changes in vaginal microbiota composition, including Lactobacillus crispatus levels, assessed at baseline (T0) and three months (T3).

The study is approved by the Ethics Committee for Human Experimentation (CESU), University of Urbino Carlo Bo, under protocol 124\_6March2025\_Lactobacillus crispatus M247\_Sisti, on 29.04.2025.

Conditions

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Atrophic Vulvovaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to one of two groups in a 2:1 (Laser-only : Laser + Crispact) Group 1: Vaginal laser therapy only. Group 2: Vaginal laser therapy + Lactobacillus crispatus M247 (Crispact®) probiotic.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vaginal Laser Therapy Only

Participants in this arm will receive three sessions of vaginal laser therapy (Monnalisa Touch® laser), administered once every 30 days.

Group Type ACTIVE_COMPARATOR

Monnalisa Touch® Laser Therapy

Intervention Type DEVICE

Monnalisa Touch® laser therapy is a non-ablative fractional CO2 laser applied to the vaginal mucosa to promote tissue regeneration and maintain vaginal health. Participants in this group will receive three sessions of laser therapy, one session every 30 days.

Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic

Participants in this arm will receive three sessions of vaginal laser therapy (Monnalisa Touch® laser), administered once every 30 days, in combination with daily administration of Lactobacillus crispatus M247 probiotic (Crispact®) containing 20 billion CFU, taken orally once daily for three months.

Group Type EXPERIMENTAL

Monnalisa Touch® Laser Therapy

Intervention Type DEVICE

Monnalisa Touch® laser therapy is a non-ablative fractional CO2 laser applied to the vaginal mucosa to promote tissue regeneration and maintain vaginal health. Participants in this group will receive three sessions of laser therapy, one session every 30 days.

Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)

Intervention Type COMBINATION_PRODUCT

Participants in this group will receive three sessions of Monnalisa Touch® laser therapy, one session every 30 days, along with daily administration of Lactobacillus crispatus M247 (Crispact®), a probiotic containing 20 billion CFU, taken orally for three months.

Interventions

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Monnalisa Touch® Laser Therapy

Monnalisa Touch® laser therapy is a non-ablative fractional CO2 laser applied to the vaginal mucosa to promote tissue regeneration and maintain vaginal health. Participants in this group will receive three sessions of laser therapy, one session every 30 days.

Intervention Type DEVICE

Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)

Participants in this group will receive three sessions of Monnalisa Touch® laser therapy, one session every 30 days, along with daily administration of Lactobacillus crispatus M247 (Crispact®), a probiotic containing 20 billion CFU, taken orally for three months.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Vaginal Laser Therapy Laser + Probiotic Therapy

Eligibility Criteria

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Inclusion Criteria

* Menopausal women with no menstrual cycle for \>12 months.
* Diagnosed with atrophic vulvovaginitis (VVA) and experiencing related symptoms (vaginal dryness, introital and profound dyspareunia, itching, burning, bleeding during intercourse).
* Symptoms related to genitourinary syndrome of menopause (GSM), including urinary urgency, increased frequency, nocturia, recurrent cystitis, or post-coital cystitis.
* Prior negative PAP test performed within one year of enrollment.
* Women who are unresponsive to or dissatisfied with prior topical estrogen therapy or who have contraindications to local and/or systemic estrogen prescription.

Exclusion Criteria

* Pregnancy or breastfeeding.
* Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva.
* Active genital and/or urinary tract infections.
* Dermatological contraindications to laser therapy.
* Ongoing systemic or local hormone therapy.
* Neurological or psychiatric disorders.
* Chronic systemic diseases of autoimmune or dysmetabolic nature.

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No