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

NCT05796921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • ProBioEtna

    collaborator UNKNOWN

  • Agnese Maria Chiara Rapisarda

    lead OTHER

Principal Investigators

  • Marco Palumbo, Prof · University of Catania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2024-06-29
Completion
2025-05-06

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05796921 on ClinicalTrials.gov