Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

NCT01558388 | Unknown Phase 4

• 1 other identifier: Spedali Civili 926
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (2)

• Vaginal lactobacillus recolonization

  3-5 weeks

• Recurrence rate of bacterial vaginosis

  3-5 weeks

Secondary Outcomes (1)

• Preterm delivery <37 weeks

  within 43 weeks of gestation

Study Arms (2)

Vaginal lactobacilli

EXPERIMENTAL

Drug: Lactobacillus acidophilus

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lactobacillus acidophilus DRUG

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

Also known as: Pregyn-S

Vaginal lactobacilli

Placebo DRUG

One vaginal tablet daily for 10 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• multiple pregnancy
• allergy to clindamycin

Sponsors & Collaborators

• Università degli Studi di Brescia: lead
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator

Study Sites (1)

Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Luana Danti, MD

  Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

• Andrea Lojacono, MD

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Obstetrics and Gynaecology

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 20, 2012
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

IT (1)