BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study

Launched by UNIVERSITY OF BRITISH COLUMBIA · Nov 25, 2008

Keywords

ClinConnect Summary

A minimum of 240 volunteer women will be recruited through participating family practice offices throughout British Columbia. Women with symptoms of BV, who also have a positive whiff test/pH test or subsequent positive vaginal swab for BV, will be asked to participate. Women will be included if they have both a positive test result for BV (whiff test/vaginal swab) and if they have any symptoms of BV present. The following criteria must be met for enrolment in the study: 1) ages 16-50 and pre-menopausal; 2) capable of giving written informed consent; 3) fluent comprehension of spoken and wr...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Women will be included whether their complaint is symptoms of BV and have a positive whiff test/vaginal swab or if they have a positive whiff test/vaginal swab and are then asked if they have any symptoms of BV present. The following criteria must be met for enrolment in the study:
• • 1. ages 16-50 and premenopausal;
• • 2. capable of giving written informed consent;
• • 3. English speaking;
• • 4. negative pregnancy test on enrolment day;
• • 5. agree to follow study protocol;
• • 6. documented BV infection by positive vaginal swab +/- positive whiff test/pH \> 4.5;
• • 7. agree to no intercourse for the 10 days of treatment (or to use non-lubricated condoms if unavoidable);
• • 8. agree not to douche or use any intravaginal products during treatment (including tampons, medications, devices);
• • 9. abstain from alcohol during the 10 days of treatment (from 24 hours before through 72 hours after taking study medication);
• • 10. agree to no new medications or antibiotics during treatment;
• • 11. no current sexually transmitted infection as determined by history, physical exam and negative swabs for chlamydia, gonorrhea, candidiasis, trichomonas;
• • 12. patient is reliable for follow up.
• Exclusion Criteria:
• The following women would be excluded from study participation:
• • 1. less than 16 or post-menopausal;
• • 2. negative vaginal swab regardless of whiff test/pH \> 4.5;
• • 3. menstruating at diagnosis;
• • 4. symptoms so severe as to make allocation to placebo unacceptable to the patient;
• • 5. currently pregnant or at high risk for pregnancy;
• • 6. current sexually transmitted infection (HIV, hepatitis, chlamydia, gonorrhea, trichomonas, HPV or HSV);
• • 7. current yeast infection as determined by history, physical and swabs;
• • 8. history of PID;
• • 9. allergy to latex or metronidazole;
• • 10. presently lactating;
• • 11. any open wound, excoriation, vaginal irritation and including bartholin's cyst/abscess as determined by physical exam;
• • 12. presence of another vulvar, vaginal or medical condition, including cervical neoplasia treatment, that might confound treatment response;
• • 13. using lithium, anti-coagulants or disulfiram drugs;
• • 14. any antifungal or antibiotic use 14 days prior to enrolment
• • 15. PAP smear done within one week of enrollment.