Clinical trial NCT06978907: Evaluation of the Efficacy and Safety of Lactobacillus Crispatus M247 (Crispact®) With Vaginal Laser Therapy in Menopausal Women With Atrophic Vulvovaginitis (VVA)
Official title: Evaluation of the Efficacy and Safety of Lactobacillus Crispatus M247 (Crispact®) in Combination With Vaginal Laser Therapy for Improving Vaginal Microbiota Composition and Symptomatology in Menopausal Women With Atrophic Vulvovaginitis: A Prospective, Multicenter, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrophic Vulvovaginitis
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2025-05-18
Enrollment: 75
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two groups:

Group 1: Vaginal laser therapy only.

Group 2: Vaginal laser therapy + Lactobacillus crispatus M247 (Crispact®) probiotic.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Vaginal Microbiota Composition (Lactobacillus crispatus Abundance)
timeFrame: Baseline (T0) and 3 months (T3).
Secondary outcomes:
measure: Change in Genitourinary Symptoms (Using the Vulvovaginal Atrophy Symptom Questionnaire)
timeFrame: Baseline (T0), Month 1 (M1), Month 2 (M2), Month 3 (M3)
measure: Safety Assessment of Probiotic Use (Adverse Events Monitoring)
timeFrame: Baseline (T0) to 3 months (T3).
Other outcomes:
Locations:
Study officials:
References:
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