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.
Female participants aged 18 to 45 years
Diagnosis of recurrent bacterial vaginosis
At least three documented episodes of bacterial vaginosis in the previous 12 months
Completion of standard antibiotic therapy for bacterial vaginosis before enrollment
Pregnancy or breastfeeding
Current use of systemic antibiotics or antifungal therapy not related to treatment of bacterial vaginosis
Known hypersensitivity to probiotic products or study components
Presence of other significant gynecological infections requiring treatment
Parallel
Lactobacillus crispatus CRP21
Dietary supplementOral 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.
Placebo
Other interventionMatching 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 to first recurrence of bacterial vaginosis
Time from randomization to the first confirmed recurrence of bacterial vaginosis during the study period.
Changes in vaginal pH
Assessment of changes in vaginal pH levels during the treatment and follow-up periods.
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.
Safety and tolerability
Incidence of adverse events and assessment of tolerability associated with Lactobacillus crispatus CRP21 supplementation.
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
