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

August 29, 2026 updated by: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

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

Recruiting

Conditions

Intervention / Treatment

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)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Emilia-Romagna
      • Forlì, Emilia-Romagna, Italy, 47121
      • Ravenna, Emilia-Romagna, Italy, 48122
        • Recruiting
        • Olympus Centro Medico Polispecialistico
        • Contact:
    • Lazio
    • Lombardy
      • Brescia, Lombardy, Italy, 25124
        • Recruiting
        • UOC Ginecologica ed Ostetricia, Poliambulanza Istituto Ospedaliero
        • Contact:
      • Pavia, Lombardy, Italy, 27100
        • Recruiting
        • Department of Obstetrics and Gynecology, Fondazione IRCCS Policlinico San Matteo, Università Degli Studi di Pavia
        • Contact:
        • Contact:
    • Piedmont
      • Turin, Piedmont, Italy, 10144
        • Recruiting
        • Department of Obstetrics and Gynecology, Ospedale Maria Vittoria
        • Contact:
    • Sicily
      • Catania, Sicily, Italy
    • Tuscany
      • Florence, Tuscany, Italy
        • Recruiting
        • Screening and Secondary Prevention Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO)
        • Contact:
      • Massa, Tuscany, Italy, 54100
        • Recruiting
        • UOC Ostetricia e Ginecologia, Ospedale Apuane, AUSL Toscana Nord-Ovest
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first recurrence of bacterial vaginosis
Time Frame: 24 weeks
Time from randomization to the first confirmed recurrence of bacterial vaginosis during the study period.
24 weeks
Changes in vaginal pH
Time Frame: Baseline to 24 weeks
Assessment of changes in vaginal pH levels during the treatment and follow-up periods.
Baseline to 24 weeks
Participant-reported vaginal symptom score
Time Frame: 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.
Baseline to 24 weeks
Safety and tolerability
Time Frame: 24 weeks
Incidence of adverse events and assessment of tolerability associated with Lactobacillus crispatus CRP21 supplementation.
24 weeks
Number of Episodes of Recurrent Bacterial Vaginosis
Time Frame: 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).
Baseline to Week 24
Incidence of Other Genitourinary Infections
Time Frame: 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.
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat University of Medical & Health Sciences

Collaborators

University of Urbino "Carlo Bo"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

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)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 29, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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