Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Study Overview
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Brief Summary
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Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.

Detailed Description
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Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.

Official Title
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Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: Vaginal acidifying gel (RepHresh)
* Drug: Metronidazole control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women of between 18-50 years of age. Confirmed current diagnosis of BV using Amsel's criteria. Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months Exclusion Criteria: Patient who received antibiotic therapy within the past two weeks. Patients who had co-existing gonorrhea or Chlamydia infection Any contraindications or sensitivity to taking the vaginal gel. Allergy to metronidazole Alcoholics or those unable to abstain from alcohol consumption. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronidazole plus gel<br>Receive metronidazole plus vaginal gel | Drug: Vaginal acidifying gel (RepHresh)<br>* placement of vaginal acidifying gel into vagina to restore normal vaginal pH.<br>* Other names: RepHresh vaginal gel.;|
| Active Comparator: Control- metronidazole alone<br>Oral Metronidazole antibiotic therapy alone | Drug: Metronidazole control<br>* oral metronidazole therapy alone<br>* Other names: metronidazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Bacterial Vaginosis | Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial vaginosis, vaginal acidifying gel, recurrence