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

Agnese Maria Chiara Rapisarda

Status: Completed

Conditions: Candidosis Vaginal; Urinary Tract Infections; Bacterial Vaginosis

Treatments: Dietary Supplement: Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05796921

163/2022/PO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain

Placebo

Placebo Comparator group

Description:

1 daily capsule of placebo

Treatment:

Dietary Supplement: placebo