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

NCT05796921 | Completed

• 1 other identifier: 163/2022/PO
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Vaginosis; Candidosis Vaginal; Urinary Tract Infections

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Well-being

  Baseline and wash-out (30 days)

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

1 daily capsule of placebo

Dietary Supplement: placebo

Interventions

Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain DIETARY_SUPPLEMENT

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.

Also known as: probiotic CA15

Active

placebo DIETARY_SUPPLEMENT

Patients allocated to placebo arm will take placebo capsules once a day for 10 consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: Women under reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agnese Maria Chiara Rapisarda: lead
• ProBioEtna: collaborator

Study Sites (1)

University of Catania

Catania, Italy, 95123, Italy

Location

Related Publications (1)

• 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 Nov 21;13(12):2651. doi: 10.3390/microorganisms13122651.

  PMID: 41471856 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Marco Palumbo, Prof

  University of Catania

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Model Details: randomized double-blind placebo-control

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: April 10, 2023
• Primary Completion: June 29, 2024
• Study Completion: May 6, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)