A Study of Vaginal Microbial Signatures for Women with Refractory Symptoms of Bacterial Vaginosis or Vaginitis
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 12-008662
Sponsor Protocol Number: 12-008662
About this study
Our aim is to establish a correlation between the vaginal microbiome and symptomatic refractory bacterial vaginosis or vaginitis with clinical diagnostic value.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Female patients 18 years of age or older.
- Patients must have completed a standard screen for infectious communicable diseases (HPV, Gonorrhea and Chlamydia) as part of their evaluation for symptomatic refractory BV or vaginitis.
- Women enrolled as normal healthy controls may have completed a standard screen for infectious communicable diseases if clinically indicated (HPV, chlamydia, gonorrhea), although not required for study participation.
- Patient must have undergone standard culture based diagnostics and at least one round of treatment with standard therapies.
- Patient presenting vaginal symptoms commonly associated with BV or vaginitis that is unresponsive to treatment and for which physician has determined that no additional therapy is available.
- Normal, healthy women without a history of bacterial vaginosis will be offered enrollment as controls.
- Women who are pregnant or nursing.
- Vulnerable adults including prisoners, or anyone unable to understand and give informed consent.
- Patient currently taking or have taken antibiotics in the past 2 weeks.
- Women enrolled as normal healthy controls must not have a history of recurrent BV or active symptoms of vaginitis at time of study entry.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Publications are currently not available