Will Lactobacillus Increase Cure Rate After Treatment of Bacterial Vaginosis and Chronic Vulvovaginal Candida
Vaginal Colonization After Treatment With Lactobacillus in Women With BV or Candida Will That Increase the Cure Rate After Treatment With Clindamycin for BV and Flucnazole for Candida
1 other identifier
observational
50
1 country
2
Brief Summary
From the earlier studies the investigators have treated women with bacterial vaginosis and cronic vulvovaginal candida. The investigators have then treated them with laktobacilli 10 days for 2 month. The investigators will continue to follow them and investigate if treatment with lactobacilli every week for 6 month will increase cure rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedAugust 14, 2019
August 1, 2019
1 year
October 30, 2014
August 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
cure rate
6 month
Secondary Outcomes (1)
colonization of lactobacilli
6 month
Interventions
Probiotic human lactobacillus (L. gasseri and L rahmnosus)
Eligibility Criteria
women with vaginal discharge with either bacterial vaginosis or candida infection
You may qualify if:
- Diagnosis of bacterial vaginosis according to Hay/Ison or with candida diagnosed with wet smear.
You may not qualify if:
- Women with chlamydia infection, Pregnancy, Herpes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Ob/Gyn, Skaraborgshospital Skövde
Skövde, 541 85, Sweden
Kvinnokliniken
Skövde, 54185, Sweden
Related Publications (2)
Larsson PG, Brandsborg E, Forsum U, Pendharkar S, Andersen KK, Nasic S, Hammarstrom 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.
PMID: 21854593RESULTPendharkar S, Brandsborg E, Hammarstrom L, Marcotte H, Larsson PG. Vaginal colonisation by probiotic lactobacilli and clinical outcome in women conventionally treated for bacterial vaginosis and yeast infection. BMC Infect Dis. 2015 Jul 3;15:255. doi: 10.1186/s12879-015-0971-3.
PMID: 26137971DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per-Göran Larsson
Department of Ob/Gyn Skaraborgs hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Consultat
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 20, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2015
Study Completion
November 1, 2015
Last Updated
August 14, 2019
Record last verified: 2019-08