An interventional study of Lactobacillus crispatus CRP21 and Placebo in Recurrent Bacterial Vaginosis, sponsored by Liaquat University of Medical & Health Sciences. Recruiting at 11 sites in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Prevention
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.
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.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's planned enrollment of 132 is above the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Lactobacillus crispatus CRP21
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.
Other: Placebo
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.
Also known as: Crispavag®
Matching placebo capsules identical in appearance to the probiotic product, administered orally once daily for 12 weeks following standard antibiotic treatment for bacterial vaginosis.
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.
Time frame: 24 weeks
Time to first recurrence of bacterial vaginosis
Time from randomization to the first confirmed recurrence of bacterial vaginosis during the study period.
Time frame: 24 weeks
Changes in vaginal pH
Assessment of changes in vaginal pH levels during the treatment and follow-up periods.
Time frame: 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.
Time frame: Baseline to 24 weeks
Safety and tolerability
Incidence of adverse events and assessment of tolerability associated with Lactobacillus crispatus CRP21 supplementation.
Time frame: 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).
Time frame: 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.
Time frame: Baseline to Week 24
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.
Of 52 interventional studies with no phase under Vaginosis, Bacterial, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 56. This study's planned 11 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Liaquat University of Medical & Health Sciences