Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Skaraborg Hospital
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Per-Goran Larsson, Skaraborg Hospital
ClinicalTrials.gov Identifier:
NCT01245322
First received: November 19, 2010
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: lactobacilli
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Skaraborg Hospital:

Primary Outcome Measures:
  • characterize lactobacilli of human vaginal origin [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
    characterize lactobacilli of human vaginal origin


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 75
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)
Arms Assigned Interventions
Active Comparator: Lactobacilli
different lactobacilli.
Drug: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245322

Locations
Norway
Gynekologklinikken Recruiting
Drammen, Norway, 3002
Contact: P-G Larsson, professor    +4732808492    p-g.larsson@vgregion.se   
Principal Investigator: Per-Göran Larsson, Professor         
Sponsors and Collaborators
Skaraborg Hospital
Karolinska University Hospital
Investigators
Principal Investigator: Per-Göran Larsson, professor Skaraborg hospital and University College of Skövde, SE-541 85 Skövde, Sweden
  More Information

No publications provided by Skaraborg Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per-Goran Larsson, professor, Skaraborg Hospital
ClinicalTrials.gov Identifier: NCT01245322     History of Changes
Other Study ID Numbers: LAV-3-BV
Study First Received: November 19, 2010
Last Updated: December 2, 2013
Health Authority: Norway: Ethics Committee

Keywords provided by Skaraborg Hospital:
treatment, lactobacilli

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

ClinicalTrials.gov processed this record on October 29, 2014