This trial is designed to study the efficacy of a synbiotic pessary on the symptoms of bacterial vaginosis compared to a placebo.
The current primary treatment for BV is oral antibiotics, which may not be suitable for some sufferers, therefore, we're conducting this study on an alternative treatment.
For this study we are looking to enrol approximately 60 generally healthy female adults from that have a history of BV.
At the moment we are recruiting for Part 1 of this study and looking approximately 10 participants who are all allocated the active product.
I have a few screening questions to go through with you today, if you're eligible to participate, We'll ask you to sign a digital consent form online and post the study product and some sample collection kits out to you in the mail
Before you start, we'll ask you to complete an online background questionnaire. This includes questions on menstrual cycle, menopause status, sexual activity, medications and hygiene habits.
Once you have received the product, the next time you start to experience BV symptoms - (eg odour, itching or discharge) you will be required to collect two vaginal swabs, you can collect these yourself at home, but you will need to drop off the initial purple capped swab to a SNP pathology laboratory within 48 hours of collection.
The other white capped swap you can store safely in your fridge until you are instructed to post it.
You'll also perform a vaginal pH test as per the instructions provided and record the result directly into our online data capture system along with completing the BV symptom questionnaire.
In the evening of Day 1 of your symptoms, you'll insert a study product pessary into the vagina before bed as per the instructions provided.
If you are menstruating when your symptoms begin, you will need to wait and start treatment after menstruation ceases on the 7th day of your cycle.
On Days 2 to 10 of your BV infection you'll complete the online BV symptom questionnaire and each evening insert another pessary using the applicator supplied.
On the 11th day you'll collect another vaginal swab and you will need to post it to the lab along with the day 1 swab that you’ve had stored in the fridge. We'll provide you with addressed pre-paid envelopes.
You'll also perform another vaginal pH test as per the instructions provided and record the result directly into our online data capture system. We will email several questionnaires for you to complete on this day also.
40 days after the start of your BV infection symptoms, we'll ask you to repeat these tests and questionnaires, including a final vaginal swab and PH Test.
You will also be asked whether you have experienced any further recurrence of BV symptoms and if you have taken other medications since completing the treatment.
This will be the completion of your participation in the study.
We'll be in touch with you regularly without the study and at each point of contact, you will be asked if you have experienced any adverse events and if you have experienced any unusual effects since the last point of contact.
You can take prescription, Over-the-counter, vitamin, mineral and/or herbal medicines throughout the study, as long as they're not for treating BV and you let us know what medications you have taken.
Please do not take or start any new therapies for BV, use douches take antibiotics (oral or topical) or antifungals during the course of the trial.
Once you have completed the study, you will be paid $100 as a thank you for your time and effort and to cover any out of pocket expenses.
Do you have any questions about the study process?
