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Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

Primary Purpose

Bacterial Vaginosis

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Lactobacillus acidophilus

Placebo

About this trial

This is an interventional treatment trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Ostetricia 1, Azienda Ospedaliera Spedali Civili di BresciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaginal lactobacilli

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Vaginal lactobacillus recolonization

Recurrence rate of bacterial vaginosis

Secondary Outcome Measures

Preterm delivery <37 weeks

Full Information

NCT ID

NCT01558388

First Posted

March 15, 2012

Last Updated

March 16, 2012

Sponsor

Università degli Studi di Brescia

Collaborators

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

1. Study Identification

Unique Protocol Identification Number

NCT01558388

Brief Title

Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi di Brescia

Collaborators

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Vaginosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vaginal lactobacilli

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Lactobacillus acidophilus

Other Intervention Name(s)

Pregyn-S

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One vaginal tablet daily for 10 days.

Primary Outcome Measure Information:

Title

Vaginal lactobacillus recolonization

Time Frame

3-5 weeks

Title

Recurrence rate of bacterial vaginosis

Time Frame

3-5 weeks

Secondary Outcome Measure Information:

Title

Preterm delivery <37 weeks

Time Frame

within 43 weeks of gestation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luana Danti, MD

Organizational Affiliation

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrea Lojacono, MD

Organizational Affiliation

Università degli Studi di Brescia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luana Danti, MD

Phone

+390303995365

12. IPD Sharing Statement

Learn more about this trial

Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

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