Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
Status:
Unknown status
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of
women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three
months and 70-80% within a year. Given the paucity of information and data regarding
pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown.
Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are
not available.
In 2013, the investigators published two manuscripts documenting a new qPCR based approach to
BV diagnosis and potentially prognosis. The method (LbRC) measures the content of
lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this
study are to validate that this metric is a reliable diagnostic of BV, by determining
sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women
and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is
to determine whether empirically determined "low" LbRC scores (1-2) in BV patients after
treatment are indicators of recurrence, and whether preemptive action, based on this score,
with more intensive treatment, delays or eliminates recurrence in these patients.
Phase:
Early Phase 1
Details
Lead Sponsor:
Wayne State University
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)