Can Lactobacillus crispatus CRP21 reduce recurrent bacterial vaginosis after antibiotics?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study will enroll women aged 18–45 with a history of recurrent bacterial vaginosis. After completing an acute episode treatment, participants are randomized to receive either the Crispavag probiotic or a placebo daily for 12 weeks, followed by 12 weeks of follow-up. The primary goal is to see if the probiotic reduces BV episodes during the treatment and post-treatment period. Safety and tolerability will also be monitored. The study aims to clarify whether restoring beneficial vaginal bacteria can sustain balance and prevent recurrence.

Why it matters

Who can join: the full rules

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

Where it's running

• Studio medico
  Forlì, Emilia-Romagna, Italy Recruiting
• Olympus Centro Medico Polispecialistico
  Ravenna, Emilia-Romagna, Italy Recruiting
• AIED Centre
  Rome, Lazio, Italy Recruiting
• Clinica Villa Margherita
  Rome, Lazio, Italy Recruiting
• Dipartimento di Ostetricia e Ginecologia, Policlinico Tor Vergata, Università Roma Tor Vergata
  Rome, Lazio, Italy Recruiting
• UOC Ginecologica ed Ostetricia, Poliambulanza Istituto Ospedaliero
  Brescia, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Davide Sisti, PhD
• Email: davide.sisti@uniurb.it
• Phone: 0722 303301

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Vagitab-T to treat bacterial vaginosis

  This study is testing if a new vaginal tablet called Vagitab-T can help people with bacterial vaginosis feel better and prevent it from coming back.

  Recruiting S.I.I.T. Srl · Timișoara, Timiș County · NCT06725888

• Transplanting vaginal microbiota to treat recurrent bacterial vaginosis

  This study is testing if a vaginal microbiota transplant can help women with recurring bacterial vaginosis feel better compared to a saline solution.

  Recruiting Phase 1/2 Massachusetts General Hospital · Boston, Massachusetts · NCT04046900

• GenSci142 as a vaginal treatment for bacterial vaginosis

  This study tests whether GenSci142 given as vaginal doses is safe and may help BV patients aged 18–50 compared with clindamycin cream.

  Recruiting at 9 sites Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 8 other locations · NCT07663838

• Vaginal gel to treat and prevent bacterial vaginosis and yeast infections

  This trial will test whether a vaginal gel called Multi-Gyn FemiTotal can treat and prevent bacterial vaginosis and vulvovaginal candidiasis in adult women.

  Recruiting Karo Pharma AB · Quatre Bornes · NCT07234786

• Using a device to treat bacterial vaginosis and fungal infections in women

  This study tests if a new medical device can help premenopausal women get rid of bacterial vaginosis and fungal infections.

  Recruiting at 3 sites Cern Corporation · Irvine, California and 2 other locations · NCT06933420

• Examining the genital microbiome of male partners of women with recurrent bacterial vaginosis

  This study is testing if the bacteria in the genital area of men can affect how often their female partners get bacterial vaginosis and whether cleaning with a certain solution can help reduce this risk.

  Recruiting Hadassah Medical Organization · Jerusalem · NCT05963711

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.