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

Liaquat University of Medical & Health Sciences

Status: Begins enrollment this month

Conditions: Atrophic Vulvovaginitis

Treatments: Device: Monnalisa Touch® Laser Therapy; Combination Product: Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06978907

L. crispatus M247/25.04.2025

Details and patient eligibility

About

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 vaginal microbiota composition, while secondary outcomes focus on symptom improvement and safety assessments.

Full description

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 to receive either laser therapy alone or laser therapy combined with the probiotic.

Primary outcomes will be assessed by changes in vaginal microbiota composition (Lactobacillus crispatus levels) at baseline (T0) and three months (T3). Secondary outcomes include changes in genitourinary symptoms assessed via a standardized questionnaire and the safety profile of the probiotic.

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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Vaginal Laser Therapy Only

Active Comparator group

Description:

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

Treatment:

Device: Monnalisa Touch® Laser Therapy

Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic

Experimental group

Description:

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.

Treatment:

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

Device: Monnalisa Touch® Laser Therapy