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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295579
• Other study ID #: 24580-53750
• Status: Completed
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2019
• Source: Skaraborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Other:
• lactobacillus (EcoVag)
Probiotic human lactobacillus (L. gasseri and L rahmnosus)

Locations

Country	Name	City	State
Sweden	Department of Ob/Gyn, Skaraborgshospital Skövde	Skövde
Sweden	Kvinnokliniken	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
Skaraborg Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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 I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure rate		6 month
Secondary	colonization of lactobacilli		6 month