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
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