The study will involve approximately 60 healthy females, aged over 18 years who experience Bacterial Vaginosis. Each participant will be asked to use the study product at their next BV episode (following enrolment) for a period of 10 days and record their symptoms.

The entire study can be completed from home, with no in clinic appointments necessary. Vaginal swabs and treatment will be self-administered by the participant.

During the BV episode you would be required to insert the pessary daily for 10 days. In addition, you would also be required to perform vaginal swabs on days 1, 11 and then lastly on day 40.

To make the timing of your involvement in this study as convenient as possible for you, we are recruiting on a rolling basis which means that your individual start date is flexible.

Please see below for more information. You can find the eligibility and registration form at the bottom of this page.

For this study, we are assessing the effectiveness of a specialised synbiotic formula in the form of a vaginal pessary.

Evidence suggests that BV occurs in response to an imbalance of the normal vaginal flora. The product being investigated in this study is a specialised synbiotic formula of probiotics and prebiotics that has been designed to lower the pH of the vagina, thus restoring the normal vaginal flora.

The product will be in pessary form, and participants will be asked to insert 1 pessary daily for 10 days upon BV onset.

As this study is placebo-controlled, you will be randomly allocated to either the active or placebo products on a chance basis (like flipping a coin). During the study period, neither you nor the study investigators will know the product you have been allocated. However, if it is necessary for your health, we are able to discover which product you have been allocated.

This study is being conducted to assess the efficacy of a synbiotic pessary on the symptoms of bacterial vaginosis compared to a placebo.

Bacterial vaginosis (BV) is the most common gynaecological condition in women of reproductive age and is estimated to affect approximately 29% of women aged 14-50. The current primary treatment for BV is oral antibiotics, which may not be feasible for some sufferers, therefore, other treatment options are being developed and studied. This study is researching a non-pharmaceutical alternative.

Your involvement in the study will be approximately 4 months. During this time, you will be required to use the study product for 10 consecutive days at your next BV episode (pending whether you are menstruating at the time).

You will be required to take vaginal swabs on days 1 and 11, and then a final swab on day 40.

You will be eligible for a $100 reimbursement for your time. The payment will be made via direct deposit to your nominated bank account once all study requirements have been met.

If you are a healthy female, with recurring BV and would like to participate, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.

This study is a decentralised study, which means that there are no visits to a central clinic required. During a BV episode you will be required to complete online questionnaires, use the study product daily for 10 days, and perform self-administered vaginal swabs on days 1, 11 and day 40 following BV onset.

The required product and swabs will be posted to you at the start of the study.

• Female aged over 18 years
• Generally healthy with no uncontrolled serious illnessesExperienced BV at least 3 times in the past 12 months, or once in the past 3 months.
• Able to provide informed consent
• Able to commit to completing the study requirements

Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

This RDC Clinical study has been approved by the National Institute of Integrative Medicine Human Research Ethics Committee under Approval Number: (0125E_2023). Trained Trial Co-ordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.