Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial
This research trial is for women aged 18 to 45 who have bacterial vaginosis (BV). We want to understand how a new treatment called FB301 helps to restore the natural balance of good bacteria in the vagina. Some participants will receive FB301 by itself, while others will get it alongside an antiseptic vaginal wash (chlorhexidine) or an antibiotic tablet (metronidazole) first. The main goal is to see if any of these combinations improve and maintain healthy vaginal bacteria over 10 weeks. Your involvement could help us find better ways to treat BV.
At a glance
What is this study about?
Bacterial vaginosis (often called BV) is a very common condition that affects many women. It happens when the natural balance of bacteria in the vagina gets upset. Instead of having mostly 'good' bacteria (like Lactobacillus), there are too many other types of bacteria. This can sometimes cause symptoms like unusual discharge, a 'fishy' smell, or discomfort, although some women don't notice any symptoms at all. BV can also increase the risk of other health issues.
This study is trying to find out if a new treatment, called FB301, can help restore and maintain a healthy balance of vaginal bacteria in women with BV. FB301 contains helpful types of bacteria, similar to those that are naturally found in a healthy vagina. We are also exploring if using FB301 after a special antiseptic wash called chlorhexidine, or after taking an antibiotic called metronidazole, works better than FB301 alone.
The main question we hope to answer is whether these treatments effectively encourage the growth of beneficial bacteria, like Lactobacillus crispatus and Lactobacillus jensenii, and keep them at healthy levels for at least 10 weeks. By participating, you would be helping researchers understand how to best treat BV and potentially prevent it from coming back.
Key takeaways
- You have bacterial vaginosis (BV) and are aged 18-45.
- This study tests a new treatment (FB301) for BV.
- It aims to restore healthy vaginal bacteria.
- You would attend up to 6 visits over approximately 10 weeks.
- You might receive FB301, an antibiotic, or an antiseptic wash.
- Your participation could help improve BV treatment for others.
Who may be eligible?
This study is looking for women between 18 and 45 years old who have bacterial vaginosis (BV). You would need to have symptoms of BV, such as unusual discharge or a 'fishy' smell, which would be confirmed by a lab test during the screening visit.
You should generally be in good health. Your body mass index (BMI) needs to be 37 or lower. If you use contraception, such as the pill, patch, or injection, or a hormonal coil, you must have been using it for at least 3 months and be willing to stick with the same method during the trial. If you don't use hormonal contraception, you'll need to agree not to start any new methods and to use condoms at certain times during the study.
It's important that you have regular periods, or if your periods have stopped due to your contraception, that has been consistent for at least 3 months. You also need to be able to understand and sign a consent form, and be willing to follow all the study's instructions.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman aged between 18 and 45?
- Do you have confirmed bacterial vaginosis (BV) symptoms?
- Do you have a BMI of 37 or less?
- Do you have regular menstrual cycles, or are your periods controlled by consistent contraception?
- Are you willing to avoid vaginal intercourse and certain vaginal products for parts of the study?
- Are you able to attend appointments and collect samples as required?
What does participation involve?
If you join this study, you would visit the study centre up to 6 times over about 10 weeks. During these visits, the medical team will take samples, including vaginal swabs and blood samples. You will also collect vaginal fluid samples at home using a special menstrual disc up to 4 times.
Depending on which group you are randomly assigned to, you will receive treatments for BV. This could include a new treatment called FB301, an antiseptic vaginal wash, and/or an antibiotic tablet. You will take these treatments over two consecutive menstrual cycles. You'll need to be comfortable collecting some samples and applying treatments yourself at home. There will also be a period where you'll need to avoid vaginal sex and using certain vaginal products like tampons or douches.
Potential risks and benefits
Locations (1)
- CRS Clinical Research Services Berlin GmbHVerified postcodeBerlin, Germany
Common questions
What is Bacterial Vaginosis (BV)?
BV is a common condition where the natural balance of bacteria in the vagina changes, leading to an overgrowth of certain types of bacteria.
What is FB301?
FB301 is a new treatment being tested in this study. It contains beneficial bacteria aiming to restore a healthy balance in the vagina.
Will I know which treatment I'm getting?
Because this is a research study, you will be randomly assigned to one of four treatment groups, and you might not know which specific treatment combination you are receiving until the study is over.
How long will the study last?
Your participation in the study will last for about 10 weeks, involving up to 6 visits to the study centre.
Can I still have sex during the study?
You will need to avoid vaginal intercourse for a certain period at the start of your treatment. After this time, if you are not using hormonal contraception, you will need to use condoms.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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