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

NCT06978907 | Completed DMC

• 1 other identifier: L. crispatus M247/25.04.2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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

Conditions

Atrophic Vulvovaginitis

Outcome Measures

Primary Outcomes (2)

• Change in Genitourinary Symptoms

  Assessment using the Vulvovaginal Atrophy Symptom Questionnaire (VASQ), evaluating symptom severity (e.g., vaginal dryness, itching, dyspareunia, urinary symptoms) from baseline (T0) to Month 3 (M3).

  Baseline (T0) to Month 3 (M3).

• Safety Assessment

  Evaluation of safety and tolerability of Lactobacillus crispatus M247 based on the incidence of adverse events throughout the study period (Baseline to Month 3).

  Baseline (T0) to Month 3 (M3).

Secondary Outcomes (1)

• Change in Vaginal Microbiota Composition (Lactobacillus crispatus Abundance)

  Baseline (T0) and 3 months (T3).

Study Arms (2)

Vaginal Laser Therapy Only

ACTIVE COMPARATOR

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

Device: Monnalisa Touch® Laser Therapy

Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic

EXPERIMENTAL

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.

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

Interventions

Monnalisa Touch® Laser Therapy 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.

Also known as: Vaginal Laser Therapy

Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic; Vaginal Laser Therapy Only

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

Also known as: Laser + Probiotic Therapy

Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: (This study is for biological females only, not based on gender identity).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: collaborator
• Liaquat University of Medical & Health Sciences: lead

Study Sites (2)

Villa Margherita Clinic

Roma, 00161, Italy

Location

Hospital State of Republic of San Marino

San Mariano, 47893, Italy

Location

Related Publications (6)

• Aldunate M, Srbinovski D, Hearps AC, Latham CF, Ramsland PA, Gugasyan R, Cone RA, Tachedjian G. Antimicrobial and immune modulatory effects of lactic acid and short chain fatty acids produced by vaginal microbiota associated with eubiosis and bacterial vaginosis. Front Physiol. 2015 Jun 2;6:164. doi: 10.3389/fphys.2015.00164. eCollection 2015.

  PMID: 26082720 BACKGROUND

• Asgharpoor H, Hadizadeh-Talasaz F, Rahmani R, Rakhshandeh H, Rahmati Z. The Effect of Citrus Aurantium Vaginal Cream on Vaginal Atrophy in Postmenopausal Women: A Quasi-experimental Study. Int J Community Based Nurs Midwifery. 2024 Jan 1;12(1):32-43. doi: 10.30476/IJCBNM.2023.98670.2251. eCollection 2024 Jan.

  PMID: 38328013 BACKGROUND

• De Seta F, Caruso S, Di Lorenzo G, Romano F, Mirandola M, Nappi RE. Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study. Maturitas. 2021 May;147:34-40. doi: 10.1016/j.maturitas.2021.03.002. Epub 2021 Mar 4.

  PMID: 33832645 BACKGROUND

• Lubian-Lopez DM, Butron-Hinojo CA, Menjon-Beltran S, Gonzalez-Mesa E, Tapiador-Albertos S, Rodriguez-Jimenez B, Fiol-Ruiz G. Effects of Non-Ablative Solid-State Vaginal Laser (SSVL) for the Treatment of Vulvovaginal Atrophy in Breast Cancer Survivors after Adjuvant Aromatase Inhibitor Therapy: Preliminary Results. J Clin Med. 2023 Aug 31;12(17):5669. doi: 10.3390/jcm12175669.

  PMID: 37685736 BACKGROUND

• Mitchell CM, Srinivasan S, Plantinga A, Wu MC, Reed SD, Guthrie KA, LaCroix AZ, Fiedler T, Munch M, Liu C, Hoffman NG, Blair IA, Newton K, Freeman EW, Joffe H, Cohen L, Fredricks DN. Associations between improvement in genitourinary symptoms of menopause and changes in the vaginal ecosystem. Menopause. 2018 May;25(5):500-507. doi: 10.1097/GME.0000000000001037.

  PMID: 29206774 BACKGROUND

• Muhleisen AL, Herbst-Kralovetz MM. Menopause and the vaginal microbiome. Maturitas. 2016 Sep;91:42-50. doi: 10.1016/j.maturitas.2016.05.015. Epub 2016 Jun 1.

  PMID: 27451320 BACKGROUND

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: July 1, 2025
• Primary Completion: November 27, 2025
• Study Completion: December 9, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)