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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Recurrent Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT07474831

Run by

Liaquat University of Medical & Health Sciences

People needed

156

Starts

2026-03-23

Expected to finish

2027-04-16

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Urbino Carlo Bo — Urbino, Pesaro And Urbino, Italy

Full record on ClinicalTrials.gov

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