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Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

NCT ID: NCT01558388

Last Updated: 2012-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vaginal lactobacilli

Group Type EXPERIMENTAL

Lactobacillus acidophilus

Intervention Type DRUG

Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One vaginal tablet daily for 10 days.

Interventions

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Lactobacillus acidophilus

Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.

Intervention Type DRUG

Placebo

One vaginal tablet daily for 10 days.

Intervention Type DRUG

Other Intervention Names

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Pregyn-S

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Federico Prefumo

Consultant in Obstetrics and Gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luana Danti, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Andrea Lojacono, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

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Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Luana Danti, MD

Role: primary

+390303995365

Other Identifiers

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Spedali Civili 926

Identifier Type: -

Identifier Source: org_study_id

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