Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota

Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota: a Randomized, Double-blind, Placebo-controlled Clinical Trial

The aim of the present randomized double-blind placebo-controlled trial is to evaluate the efficacy of a probiotic formulation, containing the probiotic strain Lacticaseibacillus rhamnosus CA15 (DSM 33960), in the treatment of vaginal dysbiosis in terms of: (i) modulation of the microbiota (increase of lactobacilli and decrease of pathogens), (ii) reduction of clinical signs of inflammation, (iii) improvement of quality of life.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Bacterial Vaginosis; Candidosis Vaginal
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain

Detailed Description

The aim of the present randomized double-blind placebo-controlled study is to evaluate the ability of the potential probiotic Lacticaseibacillus rhamnosus CA15 (DSM 33960) strain, orally administrated, to balance the vaginal microbiota of women with vaginal dysbiosis. Two hundred women, with signs and symptoms of vaginal dysbiosis, are recruited and randomly allocated to receive oral capsules containing the L. rhamnosus CA15 (DSM 33960) strain or placebo once daily for 10 days. Clinical and microbiological parameters are evaluated in three scheduled appointments: at baseline (T0), 10 days after the start of the treatment (T1), and 30 days after the end of the treatment (T2). In addition, at baseline (T0) and 30 days after the end of the treatment (T2), the quality of life will be evaluated through a quality of life assessment questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95123
    • University of Catania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, subjective vaginal discomfort);
• Presence of at least 3 Amsel criteria;
• Nugent score greater than 7;
• Lactobacillary grade greater than 2 (LBG) (according to Donders classification);
• Vaginal dysbiosis based on microbial cell count.

Exclusion Criteria:

• Presence of sexually transmitted diseases due to Chlamydia, Neisseria gonorrhoeae or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;
• Clinically evident herpes simplex infection;
• Human papillomavirus or human immunodeficiency virus infections;
• Use of antibiotics, antifungals, probiotics, or immunosuppressants within the past four weeks;
• Use of vaginal contraceptives and any other physiological or pathological condition that could potentially interfere with the results of the study (e.g. pregnancy or breastfeeding, chronic diseases, neoplastic diseases, diabetes, genital tract hemorrhages);
• Enrollment in other programs that involve the administration of products that may affect the composition of the vaginal microbiota.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 1 daily capsule of placebo	Dietary supplement: placebo; Patients allocated to placebo arm will take placebo capsules once a day for 10 consecutive days.
Active Comparator: Active; 1 daily capsule of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain (10 billion of Colony Forming Units/capsule) for 10 days	Dietary supplement: Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain; Patients allocated to the probiotic arm will take the dietary supplement, containing 10 billion of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain, once a day for 10 consecutive days.; Other Names: probiotic CA15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota	Change in the composition of the vaginal microbiota (significant reduction of pathogens responsible for vaginal dysbiosis and concomitant increase in lactobacilli)	Baseline; end of the treatment (10 days); wash-out (30 days)
Symptomatology	Change of signs (leucorrhoea, vulvovaginal erythema/edema) and symptoms (vulvar discomfort, burning, itching) associated to vaginal dysbiosis. Clinical signs and symptoms will be evaluated through a severity score on a scale of 0 (absent or normal) to 3 (severe).	Baseline; end of the treatment (10 days); wash-out (30 days)
Sign	Absence of inflammation according to Amsel's criteria and Nugent score between 0 and 3	Baseline; end of the treatment (10 days); wash-out (30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being	Change in the quality of life, based on the Short Form-36 (SF-36) questionnaire. Values ranging from 0 to 100 indicate worst and better outcomes, respectively.	Baseline and wash-out (30 days)

Collaborators and Investigators

• Sponsor: Agnese Maria Chiara Rapisarda
• Collaborators: ProBioEtna
• Investigators: Study Director: Marco Palumbo, Prof, University of Catania

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): June 29, 2024
• Study Completion (Actual): May 6, 2025

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Urinary Tract Infections; Vaginosis, Bacterial
• Other Study ID Numbers: 163/2022/PO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No