NCT05796921

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Agnese Maria Chiara Rapisarda · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-06-29
• Completion: 2025-05-06
• First posted: 2023-04-04
• Last updated: 2025-07-28

Locations

1 site across 1 country: Italy