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
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 48
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Italy
University of Catania
Catania
Time Frame
Start Date: 2023-04-10
Completion Date: 2025-05-06
Participants
Target number of participants: 200
Treatments
Active_comparator: Active
1 daily capsule of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain (10 billion of Colony Forming Units/capsule) for 10 days
Placebo_comparator: Placebo
1 daily capsule of placebo
Related Therapeutic Areas
Sponsors
Leads: Agnese Maria Chiara Rapisarda
Collaborators: ProBioEtna