What is the LACTIN-V Study?
This is a medical research study sponsored by the National Institutes of Health (NIH) Division Of Microbiology And Infectious Diseases through the Sexually Transmitted Infections Clinical Trials Group (STI-CTG) led by study doctors Craig Cohen, MD, MPH, Anke Hemmerling, MD, PhD, MPH Misa Perron-Burdick, MD, MAS and Sara Newmann, MD, MPH, from the University of California, San Francisco (UCSF) Department of Obstetrics, Gynecology and Reproductive Sciences.
The aim of this study is to test a vaginal powder made of naturally occurring probiotic, Lactobacillus crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered following a 5-day treatment with Metronidazole (MetroGel) to treat bacterial vaginosis (BV), which could reduce the incidence of BV recurrence when compared to placebo. BV is a condition many women suffer from and it increases the risk of these women of getting infected with various sexually transmitted diseases. Millions of people throughout the world could benefit from such a product. If you are a woman currently with an untreated BV infection, you may be eligible!
What will I be asked to do?
You will be asked to use an applicator filled with a test powder in your vagina once a day for 5 days, and then twice a week for the following ten weeks.
You will get a free exam and lab tests at the first study visit. If you are diagnosed with BV at this time, you will be given a 5-day course of 0.75% topical Metronidazole (MetroGel) therapy, the standard antibiotic treatment for BV. Two days after you finish the antibiotic treatment, you will return for your lab results. The results of these tests will determine if you are eligible to join the study.
If you are eligible, you will receive the pre-filled applicators and asked to use it once a day at bedtime for the next 5 days, then twice a week for the following ten weeks. Over the next 24 weeks, you will have 4 more exam visits and two telephone interviews (one visit per month) to discuss your experiences with the product. Throughout the study, you will keep a record of how you use the pre-filled applicators and how you are feeling.
Will I be paid to be in this study?
You can earn up to $630 in cash. All study exams, tests, and supplies are provided free of charge.