Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE November 19, 2010
First Posted Date  ICMJE November 22, 2010
Last Update Posted Date November 10, 2014
Study Start Date  ICMJE January 2007
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
characterize lactobacilli of human vaginal origin [ Time Frame: 24 month ]
characterize lactobacilli of human vaginal origin
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01245322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Bacterial Vaginosis Combined With Human Lactobacilli
Official Title  ICMJE Extended Antimicrobial Treatment of Bacterial Vaginosis Combined With Human Lactobacilli to Find the Best Treatment and Minimize the Risk of Relapses
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE 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
Study Arms  ICMJE Active Comparator: Lactobacilli
different lactobacilli.
Intervention: Drug: lactobacilli
Publications * Larsson PG, Brandsborg E, Forsum U, Pendharkar S, Andersen KK, Nasic S, Hammarström L, Marcotte H. Extended antimicrobial treatment of bacterial vaginosis combined with human lactobacilli to find the best treatment and minimize the risk of relapses. BMC Infect Dis. 2011 Aug 19;11:223. doi: 10.1186/1471-2334-11-223.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 19, 2010)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01245322
Other Study ID Numbers  ICMJE LAV-3-BV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Per-Goran Larsson, Skaraborg Hospital
Study Sponsor  ICMJE Skaraborg Hospital
Collaborators  ICMJE Karolinska University Hospital
Investigators  ICMJE
Principal Investigator: Per-Göran Larsson, professor Skaraborg hospital and University College of Skövde, SE-541 85 Skövde, Sweden
PRS Account Skaraborg Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP