Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

Phase 4

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: lactobacilli

• Registration Number: NCT01245322
• Lead Sponsor: Skaraborg Hospital

Brief Summary

The primary objectives of this study were to characterize lactobacilli of human vaginal origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.

Detailed Description

Nine of the vaginal Lactobacillus strains isolated from healthy Swedish women and characterized in the present study were selected for the clinical trial.All women with symptomatic BV fulfilling the inclusion criteria were consecutively offered to participate in a prospective study of adjuvant lactobacilli given in addition to antibiotics. Women included were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections. Exclusion criteria were patients with hormonal intrauterine device without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-06
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections.

Exclusion Criteria

• Exclusion criteria were patients with hormonal IUD without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactobacilli	lactobacilli	different lactobacilli.

Primary Outcome Measures

Name	Time	Method
characterize lactobacilli of human vaginal origin	24 month	characterize lactobacilli of human vaginal origin

Secondary Outcome Measures

Name	Time	Method
cure rate after 24 month	24 month	to investigate if more extended antibiotic treatment against BV, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.

Trial Locations

Locations (1)

Gynekologklinikken; 🇳🇴 Drammen, Norway