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

NCT ID: NCT02295579

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bacterial Vaginosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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lactobacillus (EcoVag)

Probiotic human lactobacillus (L. gasseri and L rahmnosus)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Skaraborg Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Per-Goran Larsson

Professor Consultat

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per-Göran Larsson

Role: PRINCIPAL_INVESTIGATOR

Department of Ob/Gyn Skaraborgs hospital

Locations

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Department of Ob/Gyn, Skaraborgshospital Skövde

Skövde, , Sweden

Site Status

Kvinnokliniken

Skövde, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 21854593 (View on PubMed)

Pendharkar 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.

Reference Type DERIVED
PMID: 26137971 (View on PubMed)

Other Identifiers

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24580-53750

Identifier Type: -

Identifier Source: org_study_id

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