NCT06978907

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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 genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety. Secondary outcomes include changes in vaginal microbiota composition.

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 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

• Atrophic Vulvovaginitis

Interventions

Type	Name	Description
DEVICE	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.
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-11-27
• Completion: 2025-12-09
• First posted: 2025-05-18
• Last updated: 2026-01-06

Locations

2 sites across 1 country: Italy