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

NCT ID: NCT05796921

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2025-05-06

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.

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.

Conditions

Bacterial Vaginosis; Candidosis Vaginal; Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active

1 daily capsule of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain (10 billion of Colony Forming Units/capsule) for 10 days

Group Type: ACTIVE_COMPARATOR

Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain

Intervention Type: 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.

Placebo

1 daily capsule of placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

probiotic CA15

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ProBioEtna

UNKNOWN

Sponsor Role: collaborator

Agnese Maria Chiara Rapisarda

OTHER

Sponsor Role: lead

Responsible Party

Agnese Maria Chiara Rapisarda

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marco Palumbo, Prof

Role: STUDY_DIRECTOR

University of Catania

Locations

University of Catania

Catania, Italy, Italy

Countries

Italy

Other Identifiers

163/2022/PO

Identifier Type: -

Identifier Source: org_study_id