Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

This study has been completed.
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: November 6, 2014
Last verified: November 2014

November 19, 2010
November 6, 2014
January 2007
October 2014   (final data collection date for primary outcome measure)
characterize lactobacilli of human vaginal origin [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
characterize lactobacilli of human vaginal origin
Same as current
Complete list of historical versions of study NCT01245322 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Treatment of Bacterial Vaginosis Combined With Human Lactobacilli
Extended Antimicrobial Treatment of Bacterial Vaginosis Combined With Human Lactobacilli to Find the Best Treatment and Minimize the Risk of Relapses

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bacterial Vaginosis
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
Active Comparator: Lactobacilli
different lactobacilli.
Intervention: Drug: lactobacilli
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.
 
Completed
75
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01245322
LAV-3-BV
No
Per-Goran Larsson, Skaraborg Hospital
Skaraborg Hospital
Karolinska University Hospital
Principal Investigator: Per-Göran Larsson, professor Skaraborg hospital and University College of Skövde, SE-541 85 Skövde, Sweden
Skaraborg Hospital
November 2014

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