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Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

This study is currently recruiting participants.
Verified March 2012 by Università degli Studi di Brescia
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
 Drug: Lactobacillus acidophilus
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Preterm delivery <37 weeks [ Time Frame: within 43 weeks of gestation ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal lactobacilli Drug: Lactobacillus acidophilus
Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.
Other Name: Pregyn-S
Placebo Comparator: Placebo Drug: Placebo
One vaginal tablet daily for 10 days.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558388

Locations
Italy
Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Luana Danti, MD     +390303995365        
Sponsors and Collaborators
Università degli Studi di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
Principal Investigator: Luana Danti, MD Azienda Ospedaliera Spedali Civili di Brescia
Principal Investigator: Andrea Lojacono, MD Università degli Studi di Brescia
  More Information

No publications provided

Responsible Party: Federico Prefumo, Consultant in Obstetrics and Gynaecology, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT01558388     History of Changes
Other Study ID Numbers: Spedali Civili 926
Study First Received: March 15, 2012
Last Updated: March 16, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013