Bacterial Vaginosis Research Study

Researchers at Massachusetts General Hospital are evaluating a new treatment to prevent recurring bacterial vaginosis.

Fast Facts

Ages
18-40

Experiencing symptoms of bacterial vaginosis

Compensation Provided

Conducted in Boston, MA

Study Background

Researchers at Massachusetts General Hospital are evaluating a new treatment to prevent recurring bacterial vaginosis.

This study is the first of its kind, focusing on a new type of treatment in a phase 1 clinical trial. It examines a special vaginal tablet containing live and helpful Lactobacillus bacteria. The goal is to see if this tablet can stop bacterial vaginosis from returning after taking antibiotics.

Participants will start by taking oral antibiotics (called Metronidazole) for a week. Then, they’ll be randomly placed into one of three groups. One group will receive a fake pill (placebo), while the other two will get the real vaginal tablets with the live bacteria. These tablets need to be put into the vagina once a day for seven days. 

During the study, participants will visit the doctors ten times over about three months. At these visits, they’ll do things like swab the vagina, collect vaginal fluid using a menstrual cup, and answer questions. Some visits will also include pelvic exams, providing urine samples, and having blood drawn. Additionally, participants will need to collect vaginal swabs at home every day and fill out a diary. 

To join the study, people must be using certain types of birth control pills or shots, or be willing to start them for the study. 

Study Background

Researchers at Massachusetts General Hospital are evaluating a new treatment to prevent recurring bacterial vaginosis.

This study is the first of its kind, focusing on a new type of treatment in a phase 1 clinical trial. It examines a special vaginal tablet containing live and helpful Lactobacillus bacteria. The goal is to see if this tablet can stop bacterial vaginosis from returning after taking antibiotics.

Participants will start by taking oral antibiotics (called Metronidazole) for a week. Then, they’ll be randomly placed into one of three groups. One group will receive a fake pill (placebo), while the other two will get the real vaginal tablets with the live bacteria. These tablets need to be put into the vagina once a day for seven days. 

During the study, participants will visit the doctors ten times over about three months. At these visits, they’ll do things like swab the vagina, collect vaginal fluid using a menstrual cup, and answer questions. Some visits will also include pelvic exams, providing urine samples, and having blood drawn. Additionally, participants will need to collect vaginal swabs at home every day and fill out a diary. 

To join the study, people must be using certain types of birth control pills or shots, or be willing to start them for the study.  

Additional Information

The purpose of this research study is to examine the effectiveness of a new treatment for recurring bacterial vaginosis.

You may qualify for this study if you meet the following criteria:

Inclusion Criteria:

  • Ages 18-40
  • Diagnosed with bacterial vaginosis, or have recently noticed unusual vaginal discharge with a strong, fishy odor
  • Willing to take a combined oral contraceptive pill or the Depo-Provera injection during the study
  • Not using an IUD or implant for birth control
  • Assigned female at birth and not currently undergoing masculinizing hormone therapy
  • Not pregnant or breastfeeding, nor have been in the past 6 months

If you choose to take part in this study, you’ll be involved in ten in-person visits over the course of about 12 weeks. 

At each visit, you’ll complete questionnaires, have vaginal swabs taken, and wear a disposable menstrual cup for around 30 minutes.

 Additionally, during the screening visit, visit 1, visit 2, visit 6, and visit 9, you’ll have blood drawn and undergo a pelvic exam. 

To help with the study, you’ll also be asked to collect daily vaginal swabs and fill out a daily electronic diary entry at home for the first five weeks.

Participants will be compensated up to $585 for participation in this study. In addition, participants will receive a parking sticker OR $30 as a travel reimbursement per visit.

There is no cost for you to participate in our research study.