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

NCT07474831 | Recruiting DMC

• 1 other identifier: 155_9gennaio2026_CRISPAVAG
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Recurrent Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Incidence of recurrent bacterial vaginosis

  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 Outcomes (6)

• Time to first recurrence of bacterial vaginosis

  24 weeks

• Changes in vaginal pH

  Baseline to 24 weeks

• Participant-reported vaginal symptom score

  Baseline to 24 weeks

• Safety and tolerability

  24 weeks

• Number of Episodes of Recurrent Bacterial Vaginosis

  Baseline to Week 24

Study Arms (2)

Lactobacillus crispatus CRP21 (Crispavag®)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

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.

Also known as: Crispavag®

Lactobacillus crispatus CRP21 (Crispavag®)

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Urbino "Carlo Bo": collaborator

Study Sites (11)

Studio medico

Forlì, Emilia-Romagna, 47121, Italy

RECRUITING

Olympus Centro Medico Polispecialistico

Ravenna, Emilia-Romagna, 48122, 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, 25124, Italy

RECRUITING

Department of Obstetrics and Gynecology, Fondazione IRCCS Policlinico San Matteo, Università Degli Studi di Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

Department of Obstetrics and Gynecology, Ospedale Maria Vittoria

Turin, Piedmont, 10144, Italy

RECRUITING

Gynecology and Obstetrics Department, San Marco Hospital

Catania, Sicily, Italy

RECRUITING

Screening and Secondary Prevention Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO)

Florence, Tuscany, Italy

RECRUITING

UOC Ostetricia e Ginecologia, Ospedale Apuane, AUSL Toscana Nord-Ovest

Massa, Tuscany, 54100, Italy

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Davide Sisti, PhD

CONTACT

0722 303301; davide.sisti@uniurb.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind with masking of participants, care providers, investigators, and outcomes assessors. The probiotic and placebo capsules are identical in appearance, packaging, and labeling to maintain blinding throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Participants with recurrent bacterial vaginosis will be randomized in a 1:1 ratio to receive either Lactobacillus crispatus CRP21 (Crispavag®) or placebo following standard antibiotic treatment. Participants will receive one capsule daily for 12 weeks and will be followed for an additional 12 weeks to evaluate recurrence of bacterial vaginosis.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 16, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): April 16, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

IT (11)