Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal acidifying gel (RepHresh)

Drug

placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.

Other names: RepHresh vaginal gel.

Metronidazole control

Drug

oral metronidazole therapy alone

Other names: metronidazole

Primary outcomes

Recurrent Bacterial Vaginosis

Time frame: 3 months

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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Oct 17, 2007
Registry last updated: Jan 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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