Recurrent Bacterial VaginosisNCT07474831
Evaluation of the Ability of Lactobacillus Crispatus CRP21 to Reduce the Incidence of Recurrent Bacterial Vaginosis
A study testing Lactobacillus crispatus CRP21 in people with Recurrent Bacterial Vaginosis, run by Liaquat University of Medical & Health Sciences at 11 sites in Italy.
Trial summary
Recurrent bacterial vaginosis is a common condition in women of reproductive age and is characterized by a disruption of the normal vaginal microbiota, with a reduction in Lactobacillus species and an overgrowth of anaerobic bacteria such as Gardnerella vaginalis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Recurrent Bacterial Vaginosis
- What is being tested?
- Lactobacillus crispatus CRP21
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 11 sitesItaly
- Study dates
- 23 Mar 2026to 16 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years
- Diagnosis of recurrent bacterial vaginosis (≥3 episodes of bacterial vaginosis within 12 months prior to enrollment)
- Presence of a diagnosis of bacterial vaginosis at the time of enrollment, carried out through the presence of 3 out of 4 of the Amsel Criteria
- Accepted written informed consent for study participation obtained prior to the start of the study
Who cannot join
- Age <18 years or >45 years
- Concomitant presence of Candida vulvovaginitis
- Pregnancy
- Breastfeeding
- Use of other therapies for the prevention of bacterial vaginosis in the previous 30 days
- Alcohol or drug abuse
- Known allergy to the components of the product used
- Lack of acceptance of written informed consent
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Italy11 sites, 11 recruiting
- Recruiting
UOC Ginecologica ed Ostetricia, Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, 25124
Lorenzo Agoni, MD, lorenzo.agoni@gmail.com
- Recruiting
Gynecology and Obstetrics Department, San Marco Hospital
Catania, Sicily
Emanuela Sampugnaro, MD, emanuela.sampugnaro@gmail.com
- Recruiting
Screening and Secondary Prevention Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO)
Florence, Tuscany
Lisa Lelli, MD, l.lelli@ispro.toscana.it
- Recruiting
Studio medico
Forlì, Emilia-Romagna, 47121
Andrea Amadori, MD, dott.amadori@gmail.com
- Recruiting
UOC Ostetricia e Ginecologia, Ospedale Apuane, AUSL Toscana Nord-Ovest
Massa, Tuscany, 54100
Alessandro Ghelardi, MD, ghelardi.alessandro@gmail.com
- Recruiting
Department of Obstetrics and Gynecology, Fondazione IRCCS Policlinico San Matteo, Università Degli Studi di Pavia
Pavia, Lombardy, 27100
Mattia Dominoni, MD, matti.domino@gmail.com
Barbara Gardella, MD, barbara.gardella@gmail.com
- Recruiting
Olympus Centro Medico Polispecialistico
Ravenna, Emilia-Romagna, 48122
Maurizio Filippini, MD, mfilippini@omniway.sm
- Recruiting
AIED Centre
Rome, Lazio
Paolo Inghirami, MD, paolo.inghirami@gmail.com
- Recruiting
Clinica Villa Margherita
Rome, Lazio
Roberto Senatori, MD, robertosenatori@gmail.com
Lucia Merlino, MD, lucia_merlino@icloud.com
- Recruiting
Dipartimento di Ostetricia e Ginecologia, Policlinico Tor Vergata, Università Roma Tor Vergata
Rome, Lazio
Anna Angela Criscuolo, MD, acriscuolo.dott73@gmail.com
- Recruiting
Department of Obstetrics and Gynecology, Ospedale Maria Vittoria
Turin, Piedmont, 10144
Liberale Viola, MD, viola.liberale@gmail.com
About this study
Official title: Evaluation of the Ability of Lactobacillus Crispatus CRP21 to Reduce the Incidence of Recurrent Bacterial Vaginosis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Recurrent bacterial vaginosis is a common condition in women of reproductive age and is characterized by a disruption of the normal vaginal microbiota, with a reduction in Lactobacillus species and an overgrowth of anaerobic bacteria such as Gardnerella vaginalis. Recurrence rates after standard antibiotic treatment are high. Lactobacillus crispatus is considered one of the most protective species for maintaining vaginal microbiota balance.
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of a probiotic supplement containing Lactobacillus crispatus CRP21 (Crispavag® capsules) in reducing the incidence of recurrent bacterial vaginosis in women diagnosed with recurrent bacterial vaginosis. After standard antibiotic treatment, participants will be randomly assigned in a 1:1 ratio to receive either the probiotic supplement or a placebo for 12 weeks.
The primary objective is to evaluate whether supplementation with Lactobacillus crispatus CRP21 reduces the incidence of recurrent bacterial vaginosis episodes compared with placebo. Participants will be followed for a total of 24 weeks, including a 12-week treatment period and a 12-week follow-up period.
Read the detailed description
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of the probiotic Lactobacillus crispatus CRP21 in reducing the incidence of recurrent bacterial vaginosis in women diagnosed with recurrent bacterial vaginosis.
Bacterial vaginosis is characterized by a disruption of the normal vaginal microbiota, with a decrease in Lactobacillus species and an overgrowth of anaerobic bacteria such as Gardnerella vaginalis. Standard antibiotic therapies, such as metronidazole, are effective in treating acute episodes but recurrence rates remain high. Lactobacillus crispatus is strongly associated with vaginal health due to its ability to produce lactic acid and antimicrobial substances that inhibit pathogenic microorganisms.
In this study, women aged 18-45 years diagnosed with recurrent bacterial vaginosis will be enrolled. Following antibiotic treatment for the acute episode, participants will be randomly assigned in a 1:1 ratio to receive either a probiotic supplement containing Lactobacillus crispatus CRP21 (Crispavag® capsules) or a placebo. The investigational product will be administered orally at a dose of one capsule per day for 12 weeks.
The total duration of participation for each subject will be 24 weeks, including a 12-week treatment period and a 12-week post-treatment follow-up period. The primary outcome is the reduction in the incidence of recurrent bacterial vaginosis episodes during the study period. Secondary outcomes include time to first recurrence, changes in vaginal pH, evaluation of symptoms such as burning and itching, incidence of other genitourinary infections, treatment adherence, tolerability, and assessment of adverse events.
The study will be conducted at multiple clinical centers in Italy and aims to enroll approximately 156 participants. Results from this trial will provide evidence on the clinical effectiveness of Lactobacillus crispatus CRP21 supplementation in preventing recurrence of bacterial vaginosis.
- Conditions
- Recurrent Bacterial Vaginosis
- Being tested
- Lactobacillus crispatus CRP21, Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus crispatus CRP21Dietary supplement
Also called Crispavag®
Oral probiotic supplement containing Lactobacillus crispatus CRP21 (Crispavag®, Pharmextracta S.p.A., Italy). Participants take one capsule daily for 12 weeks following standard antibiotic treatment for bacterial vaginosis.
PlaceboOther
Matching placebo capsules identical in appearance to the probiotic product, administered orally once daily for 12 weeks following standard antibiotic treatment for bacterial vaginosis.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus crispatus CRP21 (Crispavag®) | Experimental | Participants receive an oral probiotic supplement containing Lactobacillus crispatus CRP21 (Crispavag®) following standard antibiotic treatment for bacterial vaginosis. Participants take one capsule daily for 12 weeks and are followed for an additional 12 weeks to assess recurrence of bacterial vaginosis. Receives: Dietary Supplement: Lactobacillus crispatus CRP21 |
| Placebo | Placebo comparator | Participants receive placebo capsules identical in appearance to the probiotic product following standard antibiotic treatment for bacterial vaginosis. Participants take one capsule daily for 12 weeks and are followed for an additional 12 weeks to assess recurrence of bacterial vaginosis. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrent bacterial vaginosis
Proportion of participants experiencing at least one recurrence of bacterial vaginosis during the study period, confirmed by clinical assessment and diagnostic criteria following initial antibiotic treatment.
Measured: 24 weeks
Secondary outcomes (6)
Time to first recurrence of bacterial vaginosis
Time from randomization to the first confirmed recurrence of bacterial vaginosis during the study period.
Measured: 24 weeks
Changes in vaginal pH
Assessment of changes in vaginal pH levels during the treatment and follow-up periods.
Measured: Baseline to 24 weeks
Participant-reported vaginal symptom score
Participants will self-report vaginal symptoms including itching and burning. Each symptom will be rated on a 10-point Likert scale (0 = none, 10= worst symptom). Higher scores indicate more severe symptoms.
Measured: Baseline to 24 weeks
Safety and tolerability
Incidence of adverse events and assessment of tolerability associated with Lactobacillus crispatus CRP21 supplementation.
Measured: 24 weeks
Number of Episodes of Recurrent Bacterial Vaginosis
The number of episodes of bacterial vaginosis between T0 and Week 24 will be recorded in the patient's CRF. The presence of bacterial vaginosis will be evidenced by the presence of at least 3 of the 4 Amsel Criteria (abnormal vaginal discharge, vaginal pH greater than 4.5, positive odor test, and presence of clue cells).
Measured: Baseline to Week 24
Incidence of Other Genitourinary Infections
The incidence of other genitourinary infections during the study period will be assessed via event recording on the patient's CRF at T0, Week 12, and Week 24.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start23 Mar 2026
- Primary completion19 Mar 2027 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with recurrent bacterial vaginosis will be randomized in a 1:1 ratio to receive either Lactobacillus crispatus CRP21 (Crispavag®) or placebo following standard antibiotic treatment. Participants will receive one capsule daily for 12 weeks and will be followed for an additional 12 weeks to evaluate recurrence of bacterial vaginosis.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474831
- Sponsor's protocol ID
- 155_9gennaio2026_CRISPAVAG
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ability of Lactobacillus Crispatus CRP21 to Reduce the Incidence of Recurrent Bacterial Vaginosis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07474831
- Acronym / sponsor ID
- 155_9gennaio2026_CRISPAVAG
- Conditions
- Recurrent Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 19 Mar 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
Recurrent bacterial vaginosis is a common condition in women of reproductive age and is characterized by a disruption of the normal vaginal microbiota, with a reduction in Lactobacillus species and an overgrowth of anaerobic bacteria such as Gardnerella vaginalis. Recurrence rates after standard antibiotic treatment are high. Lactobacillus crispatus is considered one of the most protective species for maintaining vaginal microbiota balance.
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of a probiotic supplement containing Lactobacillus crispatus CRP21 (Crispavag® capsules) in reducing the incidence of recurrent bacterial vaginosis in women diagnosed with recurrent bacterial vaginosis. After standard antibiotic treatment, participants will be randomly assigned in a 1:1 ratio to receive either the probiotic supplement or a placebo for 12 weeks.
The primary objective is to evaluate whether supplementation with Lactobacillus crispatus CRP21 reduces the incidence of recurrent bacterial vaginosis episodes compared with placebo. Participants will be followed for a total of 24 weeks, including a 12-week treatment period and a 12-week follow-up period.
Detailed description
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of the probiotic Lactobacillus crispatus CRP21 in reducing the incidence of recurrent bacterial vaginosis in women diagnosed with recurrent bacterial vaginosis.
Bacterial vaginosis is characterized by a disruption of the normal vaginal microbiota, with a decrease in Lactobacillus species and an overgrowth of anaerobic bacteria such as Gardnerella vaginalis. Standard antibiotic therapies, such as metronidazole, are effective in treating acute episodes but recurrence rates remain high. Lactobacillus crispatus is strongly associated with vaginal health due to its ability to produce lactic acid and antimicrobial substances that inhibit pathogenic microorganisms.
In this study, women aged 18-45 years diagnosed with recurrent bacterial vaginosis will be enrolled. Following antibiotic treatment for the acute episode, participants will be randomly assigned in a 1:1 ratio to receive either a probiotic supplement containing Lactobacillus crispatus CRP21 (Crispavag® capsules) or a placebo. The investigational product will be administered orally at a dose of one capsule per day for 12 weeks.
The total duration of participation for each subject will be 24 weeks, including a 12-week treatment period and a 12-week post-treatment follow-up period. The primary outcome is the reduction in the incidence of recurrent bacterial vaginosis episodes during the study period. Secondary outcomes include time to first recurrence, changes in vaginal pH, evaluation of symptoms such as burning and itching, incidence of other genitourinary infections, treatment adherence, tolerability, and assessment of adverse events.
The study will be conducted at multiple clinical centers in Italy and aims to enroll approximately 156 participants. Results from this trial will provide evidence on the clinical effectiveness of Lactobacillus crispatus CRP21 supplementation in preventing recurrence of bacterial vaginosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with recurrent bacterial vaginosis will be randomized in a 1:1 ratio to receive either Lactobacillus crispatus CRP21 (Crispavag®) or placebo following standard antibiotic treatment. Participants will receive one capsule daily for 12 weeks and will be followed for an additional 12 weeks to evaluate recurrence of bacterial vaginosis.
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus crispatus CRP21 (Crispavag®) | Experimental | Dietary Supplement: Lactobacillus crispatus CRP21Participants receive an oral probiotic supplement containing Lactobacillus crispatus CRP21 (Crispavag®) following standard antibiotic treatment for bacterial vaginosis. Participants take one capsule daily for 12 weeks and are followed for an additional 12 weeks to assess recurrence of bacterial vaginosis. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive placebo capsules identical in appearance to the probiotic product following standard antibiotic treatment for bacterial vaginosis. Participants take one capsule daily for 12 weeks and are followed for an additional 12 weeks to assess recurrence of bacterial vaginosis. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-45 years
- Diagnosis of recurrent bacterial vaginosis (≥3 episodes of bacterial vaginosis within 12 months prior to enrollment)
- Presence of a diagnosis of bacterial vaginosis at the time of enrollment, carried out through the presence of 3 out of 4 of the Amsel Criteria
- Accepted written informed consent for study participation obtained prior to the start of the study
Key exclusion criteria (8 listed)
- Age <18 years or >45 years
- Concomitant presence of Candida vulvovaginitis
- Pregnancy
- Breastfeeding
- Use of other therapies for the prevention of bacterial vaginosis in the previous 30 days
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 |
|---|---|---|
| Lactobacillus crispatus CRP21Also: Crispavag®Oral probiotic supplement containing Lactobacillus crispatus CRP21 (Crispavag®, Pharmextracta S.p.A., Italy). Participants take one capsule daily for 12 weeks following standard antibiotic treatment for bacterial vaginosis. | Dietary supplement | Lactobacillus crispatus CRP21 (Crispavag®) |
| PlaceboMatching placebo capsules identical in appearance to the probiotic product, administered orally once daily for 12 weeks following standard antibiotic treatment for bacterial vaginosis. | Other | Placebo |
Primary outcome
Incidence of recurrent bacterial vaginosis
Time frame: 24 weeks
Proportion of participants experiencing at least one recurrence of bacterial vaginosis during the study period, confirmed by clinical assessment and diagnostic criteria following initial antibiotic treatment.
6 secondary outcomes
Time to first recurrence of bacterial vaginosis
Time frame: 24 weeks
Changes in vaginal pH
Time frame: Baseline to 24 weeks
Participant-reported vaginal symptom score
Time frame: Baseline to 24 weeks
Safety and tolerability
Time frame: 24 weeks
Number of Episodes of Recurrent Bacterial Vaginosis
Time frame: Baseline to Week 24
Incidence of Other Genitourinary Infections
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus crispatus CRP21 in people with Recurrent Bacterial Vaginosis, run by Liaquat University of Medical & Health Sciences at 11 sites 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davide Sisti, PhD (0722 303301, davide.sisti@uniurb.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of recurrent bacterial vaginosis (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.