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Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

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ClinicalTrials.gov Identifier: NCT01245322
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : November 10, 2014
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Per-Goran Larsson, 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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: lactobacilli Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. characterize lactobacilli of human vaginal origin [ Time Frame: 24 month ]
    characterize lactobacilli of human vaginal origin


Secondary Outcome Measures :
  1. cure rate after 24 month [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

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): NCT01245322


Locations
Norway
Gynekologklinikken
Drammen, Norway, 3002
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

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
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014

Keywords provided by Per-Goran Larsson, Skaraborg Hospital:
treatment, lactobacilli

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