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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Liaquat University of Medical & Health Sciences • ClinicalTrials.gov ID: NCT07474831

Registry updated: 2026-09-02
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Description

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.

Interventions

  • Lactobacillus crispatus CRP21 (Dietary supplement)
    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.
  • Placebo (Other)
    Matching placebo capsules identical in appearance to the probiotic product, administered orally once daily for 12 weeks following standard antibiotic treatment for bacterial vaginosis.

Eligibility criteria

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

Conditions

Recurrent Bacterial Vaginosis

Locations

  • Studio medico — Forlì, Emilia-Romagna, Italy
  • Olympus Centro Medico Polispecialistico — Ravenna, Emilia-Romagna, Italy
  • AIED Centre — Rome, Lazio, Italy
  • Clinica Villa Margherita — Rome, Lazio, Italy
  • Dipartimento di Ostetricia e Ginecologia, Policlinico Tor Vergata, Università Roma Tor Vergata — Rome, Lazio, Italy
  • UOC Ginecologica ed Ostetricia, Poliambulanza Istituto Ospedaliero — Brescia, Lombardy, Italy
  • Department of Obstetrics and Gynecology, Fondazione IRCCS Policlinico San Matteo, Università Degli Studi di Pavia — Pavia, Lombardy, Italy
  • Department of Obstetrics and Gynecology, Ospedale Maria Vittoria — Turin, Piedmont, Italy
  • Gynecology and Obstetrics Department, San Marco Hospital — Catania, Sicily, Italy
  • Screening and Secondary Prevention Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO) — Florence, Tuscany, Italy
  • UOC Ostetricia e Ginecologia, Ospedale Apuane, AUSL Toscana Nord-Ovest — Massa, Tuscany, Italy
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record