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NCT Number: NCT05796921

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

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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Candidosis Vaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Male Urogenital Diseases Mycoses Urinary Tract Infections Urogenital Diseases Urologic Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Catania

Catania, Italy, 95123

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: probiotic CA15

Placebo

Dietary Supplement

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

Primary outcomes

  1. Microbiota

    Time frame: Baseline; end of the treatment (10 days); wash-out (30 days)

    Change in the composition of the vaginal microbiota (significant reduction of pathogens responsible for vaginal dysbiosis and concomitant increase in lactobacilli)

  2. Symptomatology

    Time frame: Baseline; end of the treatment (10 days); wash-out (30 days)

    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).

  3. Sign

    Time frame: Baseline; end of the treatment (10 days); wash-out (30 days)

    Absence of inflammation according to Amsel's criteria and Nugent score between 0 and 3

Secondary outcomes

  1. Well-being

    Time frame: Baseline and wash-out (30 days)

    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.

Sponsors and collaborators

Lead sponsor

Agnese Maria Chiara Rapisarda

Other

Collaborators

  • ProBioEtna

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 4, 2023
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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