Clinical trial NCT05796921: Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bacterial Vaginosis
Candidosis Vaginal
Urinary Tract Infections
Lead sponsor: Universita degli Studi di Catania
Sponsor class: OTHER
Collaborators: name: ProBioEtna
First posted: 2023-04-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double-blind placebo-control
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Microbiota
timeFrame: Baseline; end of the treatment (10 days); wash-out (3 months)
measure: Symptomatology
timeFrame: Baseline; end of the treatment (10 days); wash-out (3 months)
measure: Sign
timeFrame: Baseline; end of the treatment (10 days); wash-out (3 months)
Secondary outcomes:
measure: Well-being
timeFrame: Baseline; end of the treatment (10 days); wash-out (3 months)
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
Study officials:
affiliation: University of Catania
name: Marco M Panella, Prof
role: STUDY_DIRECTOR
References: