- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01558388
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
-
-
-
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
|
One vaginal tablet daily for 10 days.
|
EXPERIMENTAL: Vaginal lactobacilli
|
Lactobacillus acidophilus 500 million colony-forming units/tablets.
One vaginal tablet daily for 10 days.
Other Names:
|
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.
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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-
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