Recurrent Bacterial Vaginosis
Conditions
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTLactobacillus crispatus CRP21
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.
OTHERPlacebo
Matching placebo capsules identical in appearance to the probiotic product, administered orally once daily for 12 weeks following standard antibiotic treatment for bacterial vaginosis.
Sponsors
Liaquat University of Medical & Health Sciences
University of Urbino "Carlo Bo"
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study is double-blind with masking of participants, care providers, investigators, and outcomes assessors. The probiotic and placebo capsules are identical in appearance, packaging, and labeling to maintain blinding throughout the study.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of recurrent bacterial vaginosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first recurrence of bacterial vaginosis | 24 weeks | Time from randomization to the first confirmed recurrence of bacterial vaginosis during the study period. |
| Changes in vaginal pH | Baseline to 24 weeks | Assessment of changes in vaginal pH levels during the treatment and follow-up periods. |
| Participant-reported vaginal symptom score | Baseline to 24 weeks | 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 | 24 weeks | Incidence of adverse events and assessment of tolerability associated with Lactobacillus crispatus CRP21 supplementation. |
| Number of Episodes of Recurrent Bacterial Vaginosis | Baseline to Week 24 | 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). |
| Incidence of Other Genitourinary Infections | Baseline to Week 24 | 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. |
Countries
Italy
Contacts
CONTACTDavide Sisti, PhD
Outcome results
None listed