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

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.

Timeline

Start

2025-07-01

Primary completion

2025-11-27

Completion

2025-12-09

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications