Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Università degli Studi di Brescia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Azienda Ospedaliera Spedali Civili di Brescia
Information provided by (Responsible Party):
Federico Prefumo, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01558388
First received: March 15, 2012
Last updated: March 16, 2012
Last verified: March 2012

March 15, 2012
March 16, 2012
September 2009
December 2012   (final data collection date for primary outcome measure)
  • Vaginal lactobacillus recolonization [ Time Frame: 3-5 weeks ] [ Designated as safety issue: No ]
  • Recurrence rate of bacterial vaginosis [ Time Frame: 3-5 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01558388 on ClinicalTrials.gov Archive Site
Preterm delivery <37 weeks [ Time Frame: within 43 weeks of gestation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Vaginosis
  • Drug: Lactobacillus acidophilus
    Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.
    Other Name: Pregyn-S
  • Drug: Placebo
    One vaginal tablet daily for 10 days.
  • Experimental: Vaginal lactobacilli
    Intervention: Drug: Lactobacillus acidophilus
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Not Provided
Italy
 
NCT01558388
Spedali Civili 926
No
Federico Prefumo, Università degli Studi di Brescia
Università degli Studi di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
Principal Investigator: Luana Danti, MD Azienda Ospedaliera Spedali Civili di Brescia
Principal Investigator: Andrea Lojacono, MD Università degli Studi di Brescia
Università degli Studi di Brescia
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP