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Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

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ClinicalTrials.gov Identifier: NCT01558388
Recruitment Status : Unknown
Verified March 2012 by Federico Prefumo, Università degli Studi di Brescia.
Recruitment status was:  Recruiting
First Posted : March 20, 2012
Last Update Posted : March 20, 2012
Sponsor:
Collaborator:
Azienda Ospedaliera Spedali Civili di Brescia
Information provided by (Responsible Party):
Federico Prefumo, Università degli Studi di Brescia

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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Lactobacillus acidophilus Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Vaginal lactobacillus recolonization [ Time Frame: 3-5 weeks ]
  2. Recurrence rate of bacterial vaginosis [ Time Frame: 3-5 weeks ]

Secondary Outcome Measures :
  1. Preterm delivery <37 weeks [ Time Frame: within 43 weeks of gestation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

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