Treatment of Bacterial Vaginosis Combined With Human Lactobacilli
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Skaraborg Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Skaraborg Hospital
Collaborator:
Karolinska University Hospital
Information provided by:
Skaraborg Hospital
ClinicalTrials.gov Identifier:
NCT01245322
First received: November 19, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | November 19, 2010 | ||||
| Last Updated Date | November 19, 2010 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
characterize lactobacilli of human vaginal origin [ Time Frame: 24 month ] [ Designated as safety issue: Yes ] characterize lactobacilli of human vaginal origin |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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 BV, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse. |
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| Detailed Description | Nine of the vaginal Lactobacillus strains isolated from healthy Swedish women and characterised 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 IUD without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| 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 |
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| Study Arm (s) | Active Comparator: Lactobacilli
different lactobacilli.
Intervention: Drug: lactobacilli |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Estimated Completion Date | March 2011 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01245322 | ||||
| Other Study ID Numbers ICMJE | LAV-3-BV | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | P-G Larsson Professor, 1Department of Obstetrics and Gynaecology Kärnsjukhuset, Skaraborg hospital and University College of Skövde, SE-541 85 Skövde, Sweden | ||||
| Study Sponsor ICMJE | Skaraborg Hospital | ||||
| Collaborators ICMJE | Karolinska University Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Skaraborg Hospital | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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