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

RecruitingNAAges 18 Years - 45 YearsFemaleLiaquat University of Medical & Health Sciences
NCT07474831 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 supplemen

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📋 Eligibility rules (as published)
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
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What it tests

  • Lactobacillus crispatus CRP21
  • Placebo
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Where

11 sites
Studio medico
Forlì, Italy
Olympus Centro Medico Polispecialistico
Ravenna, Italy
AIED Centre
Rome, Italy
Clinica Villa Margherita
Rome, Italy
Dipartimento di Ostetricia e Ginecologia, Policlinico Tor Vergata, Università Roma Tor Vergata
Rome, Italy
UOC Ginecologica ed Ostetricia, Poliambulanza Istituto Ospedaliero
Brescia, Italy
Department of Obstetrics and Gynecology, Fondazione IRCCS Policlinico San Matteo, Università Degli Studi di Pavia
Pavia, Italy
Department of Obstetrics and Gynecology, Ospedale Maria Vittoria
Turin, Italy

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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