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Will Lactobacillus Increase Cure Rate After Treatment of Bacterial Vaginosis and Chronic Vulvovaginal Candida

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ClinicalTrials.gov Identifier: NCT02295579
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Per-Goran Larsson, Skaraborg Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Bacterial Vaginosis Other: lactobacillus (EcoVag)

Detailed Description:

Clinical diagnosis of bacterial vaginosis using air dried smears combined with Hay/Ison classification. Test of cure every month or every menstrual cycle using self taken smears. The cure will be if the woman are in group 1 according to Hay/Ison classification. This will also allow us to use molecular diagnosis of BV to test cure and compare this with hay/Ison.

Test of cure for candida patiens are no visibel candida on wet smear and free of symtoms of candida.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: 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
Actual Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Groups and Cohorts
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Intervention Details:
  • Other: lactobacillus (EcoVag)
    Probiotic human lactobacillus (L. gasseri and L rahmnosus)

Outcome Measures
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Primary Outcome Measures :
  1. cure rate [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. colonization of lactobacilli [ Time Frame: 6 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
women with vaginal discharge with either bacterial vaginosis or candida infection
Criteria

Inclusion Criteria:

  • Diagnosis of bacterial vaginosis according to Hay/Ison or with candida diagnosed with wet smear.

Exclusion Criteria:

  • Women with chlamydia infection, Pregnancy, Herpes
Contacts and Locations
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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): NCT02295579


Locations
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Sweden
Department of Ob/Gyn, Skaraborgshospital Skövde
Skövde, Sweden, 541 85
Kvinnokliniken
Skövde, Sweden, 54185
Sponsors and Collaborators
Skaraborg Hospital
Investigators
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Principal Investigator: Per-Göran Larsson Department of Ob/Gyn Skaraborgs hospital
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Per-Goran Larsson, Professor Consultat, Skaraborg Hospital
ClinicalTrials.gov Identifier: NCT02295579    
Other Study ID Numbers: 24580-53750
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Vaginitis