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Microorganisms
Volume 13
Issue 12
10.3390/microorganisms13122651
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Oral Administration of the Probiotic Lacticaseibacillus rhamnosus CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study

by
Alessandra Pino
1,2,
Amanda Vaccalluzzo
1,
Stefano Cianci
3,
Marco Palumbo
4,
Giuseppe Caruso
4,
Cinzia Caggia
1,2 and
Cinzia L Randazzo
1,2,*
1
Department of Agriculture, Food and Environment, University of Catania, 95123 Catania, Italy
2
ProBioEtna SRL Spin off of the University of Catania, 95123 Catania, Italy
3
Unit of Gynecology and Obstetrics, Policlinico “G. Martino”, Department of Human Pathology of Adult and Childhood “G. Barresi”, University of Messina, 98125 Messina, Italy
4
Department of General Surgery and Medical Surgical Specialties, Gynaecological Clinic, School of Medicine, University of Catania, 95123 Catania, Italy
*
Author to whom correspondence should be addressed.
Microorganisms 2025, 13(12), 2651; https://doi.org/10.3390/microorganisms13122651
Submission received: 7 October 2025 / Revised: 11 November 2025 / Accepted: 18 November 2025 / Published: 21 November 2025
(This article belongs to the Section Antimicrobial Agents and Resistance)
Versions Notes

Abstract

Probiotics represent a valuable approach to boost vaginal health. A randomized double-blind placebo-controlled study was conducted to confirm the health benefits of the orally administered probiotic Lacticaseibacillus rhamnosus CA15 strain in a large cohort of women with bacterial vaginosis and mixed vaginitis, mainly related to mild aerobic vaginitis and vulvovaginal candidiasis. Recruited women were randomly assigned in a 1:1 ratio to receive, for 10 days, oral capsules containing 1 × 1010 colony-forming units of the L. rhamnosus CA15 strain (Active group) or a placebo (Placebo group). Two-hundred women completed this study. Clinical and microbiological parameters were assessed at baseline (T0), 10 days (T1), and 30 days post-treatment (T2). In addition, quality of life was evaluated at T0 and T2. The study protocol was registered on clinicaltrials.gov (ID: NCT05796921). The oral administration of the L. rhamnosus CA15 strain resulted in significant improvements in clinical characteristics of vaginal dysbiosis as well as changes in the vaginal microbiota composition. Furthermore, participants allocated to the Active group reported enhancements in physical and psychological health, social relations, environment, and overall quality of life. No significant changes were observed in the Placebo group. The present study highlights the ability of the L. rhamnosus CA15 to manage vaginal dysbiosis, offering new perspectives for the treatment and prevention of common gynecological disorders.
Keywords: probiotics; microbial dysbiosis; quality of life; women’s health; Lacticaseibacillus rhamnosus probiotics; microbial dysbiosis; quality of life; women’s health; Lacticaseibacillus rhamnosus

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MDPI and ACS Style

Pino, A.; Vaccalluzzo, A.; Cianci, S.; Palumbo, M.; Caruso, G.; Caggia, C.; Randazzo, C.L. Oral Administration of the Probiotic Lacticaseibacillus rhamnosus CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study. Microorganisms 2025, 13, 2651. https://doi.org/10.3390/microorganisms13122651

AMA Style

Pino A, Vaccalluzzo A, Cianci S, Palumbo M, Caruso G, Caggia C, Randazzo CL. Oral Administration of the Probiotic Lacticaseibacillus rhamnosus CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study. Microorganisms. 2025; 13(12):2651. https://doi.org/10.3390/microorganisms13122651

Chicago/Turabian Style

Pino, Alessandra, Amanda Vaccalluzzo, Stefano Cianci, Marco Palumbo, Giuseppe Caruso, Cinzia Caggia, and Cinzia L Randazzo. 2025. "Oral Administration of the Probiotic Lacticaseibacillus rhamnosus CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study" Microorganisms 13, no. 12: 2651. https://doi.org/10.3390/microorganisms13122651

APA Style

Pino, A., Vaccalluzzo, A., Cianci, S., Palumbo, M., Caruso, G., Caggia, C., & Randazzo, C. L. (2025). Oral Administration of the Probiotic Lacticaseibacillus rhamnosus CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study. Microorganisms, 13(12), 2651. https://doi.org/10.3390/microorganisms13122651

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