Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01558388
• Other study ID #: Spedali Civili 926
• Status: Recruiting
• Phase: Phase 4
• First received: March 15, 2012
• Last updated: March 16, 2012
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
Italy	Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Brescia	Azienda Ospedaliera Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal lactobacillus recolonization		3-5 weeks	No
Primary	Recurrence rate of bacterial vaginosis		3-5 weeks	No
Secondary	Preterm delivery <37 weeks		within 43 weeks of gestation	No