Bacterial VaginosisNCT05796921
Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota
A study testing Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain in people with Bacterial Vaginosis and Candidosis Vaginal, run by Agnese Maria Chiara Rapisarda at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis, Candidosis Vaginal, Urinary Tract Infections
- What is being tested?
- Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2023to 6 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota: a Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Read the 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.
- Being tested
- Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain, placebo
- Medical subject headings
- Vaginosis, Bacterial, Candidiasis, Vulvovaginal, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strainDietary supplement
Also called probiotic CA15
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.
placeboDietary supplement
Patients allocated to placebo arm will take placebo capsules once a day for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 1 daily capsule of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain (10 billion of Colony Forming Units/capsule) for 10 days Receives: Dietary Supplement: Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain |
| Placebo | Placebo comparator | 1 daily capsule of placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota
Change in the composition of the vaginal microbiota (significant reduction of pathogens responsible for vaginal dysbiosis and concomitant increase in lactobacilli)
Measured: Baseline; end of the treatment (10 days); wash-out (30 days)
Symptomatology
Change of signs (leucorrhoea, vulvovaginal erythema/edema) and symptoms (vulvar discomfort, burning, itching) associated to vaginal dysbiosis. Clinical signs and symptoms will be evaluated through a severity score on a scale of 0 (absent or normal) to 3 (severe).
Measured: Baseline; end of the treatment (10 days); wash-out (30 days)
Sign
Absence of inflammation according to Amsel's criteria and Nugent score between 0 and 3
Measured: Baseline; end of the treatment (10 days); wash-out (30 days)
Secondary outcomes (1)
Well-being
Change in the quality of life, based on the Short Form-36 (SF-36) questionnaire. Values ranging from 0 to 100 indicate worst and better outcomes, respectively.
Measured: Baseline and wash-out (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start10 Apr 2023
- Primary completion29 Jun 2024
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double-blind placebo-control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agnese Maria Chiara Rapisarda
- Sponsor type
- University, hospital or other
- Collaborators
- ProBioEtna
- Responsible party
- Sponsor-investigator, Agnese Maria Chiara Rapisarda, University of Catania
- Investigators
- Marco Palumbo, Prof, Study director, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796921
- Sponsor's protocol ID
- 163/2022/PO
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pino A, Vaccalluzzo A, Cianci S, Palumbo M, Caruso G, Caggia C, Randazzo CL. Oral Administration of the Probiotic Lacticaseibacillus rhamnosus CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study. Microorganisms. 2025 Nov 21;13(12):2651. doi: 10.3390/microorganisms13122651.
PubMed 41471856
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05796921
- Acronym / sponsor ID
- 163/2022/PO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Agnese Maria Chiara RapisardaUniversity, hospital or other
- Collaborators
- ProBioEtna
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized double-blind placebo-control
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain1 daily capsule of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain (10 billion of Colony Forming Units/capsule) for 10 days |
| Placebo | Placebo comparator | Dietary Supplement: placebo1 daily capsule of placebo |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strainAlso: probiotic CA15Patients 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 | Active |
| placeboPatients allocated to placebo arm will take placebo capsules once a day for 10 consecutive days. | Dietary supplement | Placebo |
Primary outcome
Microbiota
Time frame: Baseline; end of the treatment (10 days); wash-out (30 days)
Change in the composition of the vaginal microbiota (significant reduction of pathogens responsible for vaginal dysbiosis and concomitant increase in lactobacilli)
Symptomatology
Time frame: Baseline; end of the treatment (10 days); wash-out (30 days)
Change of signs (leucorrhoea, vulvovaginal erythema/edema) and symptoms (vulvar discomfort, burning, itching) associated to vaginal dysbiosis. Clinical signs and symptoms will be evaluated through a severity score on a scale of 0 (absent or normal) to 3 (severe).
Sign
Time frame: Baseline; end of the treatment (10 days); wash-out (30 days)
Absence of inflammation according to Amsel's criteria and Nugent score between 0 and 3
1 secondary outcome
Well-being
Time frame: Baseline and wash-out (30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Derived from this study: PubMed 41471856Pino A, Vaccalluzzo A, Cianci S, Palumbo M, Caruso G, Caggia C, Randazzo CL. Oral Administration of the Probiotic Lacticaseibacillus rhamnosus CA15 in a Large Cohort of Women with Bacterial Vaginosis and Mixed Vaginitis: Clinical Evidence from a Randomized, Double-Blind, Placebo-Controlled Study. Microorganisms. 2025 Nov 21;13(12):2651. doi: 10.3390/microorganisms13122651.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Palumbo, Prof study director
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain in people with Bacterial Vaginosis and Candidosis Vaginal, run by Agnese Maria Chiara Rapisarda at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota (time frame: Baseline; end of the treatment (10 days); wash-out (30 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.