Evaluation of the Ability of Lactobacillus Crispatus CRP21 to Reduce the Incidence of Recurrent Bacterial Vaginosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Bacterial Vaginosis
• Intervention / Treatment: Dietary supplement: Lactobacillus crispatus CRP21; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pesaro And Urbino
    • Urbino, Pesaro And Urbino, Italy
      • University of Urbino Carlo Bo
      • Contact: Davide Sisti, PhD; Email: davide.sisti@uniurb.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Willingness to comply with study procedures and follow-up visits
• Provision of written informed consent

Exclusion Criteria:

• 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
• Use of vaginal probiotic products within 30 days prior to enrollment
• Participation in another clinical trial within the previous 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus crispatus CRP21 (Crispavag®); 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; 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.; Other Names: Crispavag®
Placebo Comparator: Placebo; 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; Matching placebo capsules identical in appearance to the probiotic product, administered orally once daily for 12 weeks following standard antibiotic treatment for bacterial vaginosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first recurrence of bacterial vaginosis	Time from randomization to the first confirmed recurrence of bacterial vaginosis during the study period.	24 weeks
Changes in vaginal pH	Assessment of changes in vaginal pH levels during the treatment and follow-up periods.	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.	Baseline to 24 weeks
Safety and tolerability	Incidence of adverse events and assessment of tolerability associated with Lactobacillus crispatus CRP21 supplementation.	24 weeks

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: University of Urbino "Carlo Bo"

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2026
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): April 16, 2027

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: 155_9gennaio2026_CRISPAVAG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No