Probiotic Versus Placebo as Adjuvant for Bacterial Vagino... | NCT01558388

Studies
Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

NCT01558388

Sponsor

Università degli Studi di Brescia

Status

Unknown status

Last Update Posted

Mar 20, 2012Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Bacterial Vaginosis

Interventions

Lactobacillus acidophilus
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Mar 15, 2012

First Submission Date that Met QC Criteria

Mar 16, 2012

First Posted Date

Mar 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Federico Prefumo, Consultant in Obstetrics and Gynaecology, Università degli Studi di BresciaPrincipal Investigator

Lead Sponsor

Università degli Studi di BresciaOTHER

Collaborators

Name	Class
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal lactobacilli	Experimental		Drug: Lactobacillus acidophilus
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactobacillus acidophilus	Drug	Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.	Vaginal lactobacilli

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luana Danti, MD	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	Principal Investigator
Andrea Lojacono, MD	Università degli Studi di Brescia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia	Recruiting	Brescia		25123	Italy

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C100843	Lacteol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided