Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

March 16, 2012 updated by: Federico Prefumo, Università degli Studi di Brescia

Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy

Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia
        • Contact:
          • Luana Danti, MD
          • Phone Number: +390303995365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnancy
  • gestational age 12-32 weeks
  • diagnosis of bacterial vaginosis
  • treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days

Exclusion Criteria:

  • multiple pregnancy
  • allergy to clindamycin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
One vaginal tablet daily for 10 days.
EXPERIMENTAL: Vaginal lactobacilli
Drug: Lactobacillus acidophilus
Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.
Other Names:
  • Pregyn-S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vaginal lactobacillus recolonization
Time Frame: 3-5 weeks
3-5 weeks
Recurrence rate of bacterial vaginosis
Time Frame: 3-5 weeks
3-5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Preterm delivery <37 weeks
Time Frame: within 43 weeks of gestation
within 43 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Collaborators

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Luana Danti, MD, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Principal Investigator: Andrea Lojacono, MD, Università degli Studi di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spedali Civili 926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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