Treatment of Bacterial Vaginosis Combined With Human Lactobacilli
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Extended Antimicrobial Treatment of Bacterial Vaginosis Combined With Human Lactobacilli to Find the Best Treatment and Minimize the Risk of Relapses|
- characterize lactobacilli of human vaginal origin [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]characterize lactobacilli of human vaginal origin
- cure rate after 24 month [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Lactobacilli
women were given a seven days course of daily 2% vaginal clindamycin cream (Dalacin vaginal cream 2%, Pfizer Norway Ltd) together with oral clindamycin 300 mg BID for 7 days (Dalacin 300 mg, Pfizer Norway Ltd). Oral clindamycin treatment was also given to the patient's sexual partner.
Other Name: Treatments with differnt lactobacilli two zidovaltreatments
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245322
|Drammen, Norway, 3002|
|Contact: P-G Larsson, professor +4732808492 firstname.lastname@example.org|
|Principal Investigator: Per-Göran Larsson, Professor|
|Principal Investigator:||Per-Göran Larsson, professor||Skaraborg hospital and University College of Skövde, SE-541 85 Skövde, Sweden|