Who is sponsoring NCT05796921?

NCT05796921 is sponsored by Agnese Maria Chiara Rapisarda.

What condition does NCT05796921 study?

NCT05796921 studies Bacterial Vaginosis, Candidosis Vaginal, Urinary Tract Infections.

Is NCT05796921 still recruiting?

NCT05796921 is currently completed. Last updated 28 July 2025.

Last reviewed 2025-07-28 · How we verify

NCT05796921

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 28 July 2025

What this trial tests

NA trial testing Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain in Bacterial Vaginosis in 200 participants. Completed in 6 May 2025.

Timeline

10 April 2023

Primary endpoint
29 June 2024

6 May 2025

Quick facts

Lead sponsor	Agnese Maria Chiara Rapisarda
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	200
Start date	10 April 2023
Primary completion	29 June 2024
Estimated completion	6 May 2025
Sites	1 location across Italy

Drugs / interventions tested

Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain
placebo

Conditions studied

Bacterial Vaginosis — all drugs for Bacterial Vaginosis →
Candidosis Vaginal — all drugs for Candidosis Vaginal →
Urinary Tract Infections — all drugs for Urinary Tract Infections →

Sponsor

Agnese Maria Chiara Rapisarda

Who can join

Adults 18 to 48, female only, with Bacterial Vaginosis or Candidosis Vaginal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Oral Administration of the Probiotic <i>Lacticaseibacillus rhamnosus</i> CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study.
Pino A, Vaccalluzzo A, Cianci S, Palumbo M, et al · · 2025 · PMID 41471856 · DOI 10.3390/microorganisms13122651
Oral Administration of the Probiotic <em>Lacticaseibacillus rhamnosus</em> CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study
Pino A, Vaccalluzzo A, Cianci S, Palumbo M, et al · · 2025 · DOI 10.20944/preprints202509.2269.v1

Verify or expand the search:

Other recruiting trials for Bacterial Vaginosis

Currently open trials in the same condition.

NCT07234786 — Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections · NA · recruiting
NCT06458543 — Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age · Phase 4 · recruiting
NCT06263465 — Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis · NA · recruiting
NCT05753813 — Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome · EARLY_PHASE1 · recruiting
NCT06616168 — Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05796921 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Agnese Maria Chiara Rapisarda
Last refreshed: 28 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05796921.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing