Many women struggle with intimate health concerns, including vaginal dryness and irritation, and urinary symptoms. These are especially common during peri-menopause and postmenopause. More research is needed to understand and protect the female intimate microbiome.
This study aims to explore the user experience of a new intimate serum: the B.Y.M. Microbiome Serum. This product, containing a natural organism called ‘Bdellovibrio bacteriovorus’, has been designed to support the maintenance and protection of the female intimate microbiome. The serum is applied externally to the genital area as a protective and moisturising barrier, aimed at allowing healthy female microbes to flourish.
This research is in collaboration with the University of Reading and B.Y.M. Technologies, a female-led organisation focused on creating new solutions that protect the female intimate microbiome.
The purpose of the study is to better understand this new intimate serum. We are interested in learning more about the user experience and the long-term tolerance and effectiveness of the serum. The study also aims to explore how application of the serum may impact factors such as wellbeing, quality of life, and confidence.
Approximately 60 participants will take part in this research.
UK-based participants that meet the following criteria:
There are several criteria that place participants in a subgroup that is beyond the scope of this study, and would mean you are not able to take part on this occasion. This includes but is not limited to: certain experiences of UTI, and participants who have certain medical conditions, use certain medications, or have had certain surgeries/procedures. Please complete the screening questionnaire to confirm your eligibility to participate.
For answers to frequently asked questions, click here.
This six-month study involves completing a series of brief online surveys, applying an intimate serum to the external genital area, and providing swabs with vaginal and (external) labia-perineum microbiome samples. Participants can complete this entire study from their own home.
There are two different participant groups in this study, described below. Participation in both groups will take six months in total, split into two consecutive three-month periods:
During the screening questionnaire, you will be asked which group you would prefer to join. We need participants for both groups.
Here is what participants in each group will be asked to do:
GROUP 1: You will be asked to complete short weekly and fortnightly surveys during an initial three-month period, at the end of which you will collect one vaginal swab sample and one labia-perineum swab sample. You will also use a pH test kit to determine the pH level of the vagina (how acidic, neutral, or alkaline it is). Then, during a second three-month period commencing directly after the first three months, you will apply the intimate serum every day and continue to complete weekly and fortnightly surveys. You will then collect another vaginal swab sample and labia-perineum swab sample.
GROUP 2: You will complete the same activities as Group 1, with the addition of three extra labia-perineum swab samples to be collected during the second three-month period. These three extra samples will need to be collected during a single 24-hour period, in the morning, evening, and following morning. It’s important that all three extra samples are collected at the times instructed.
In both groups, you will be required to return your samples and pH test results to the laboratory via a Royal Mail postbox as soon as possible. This will either be the same day as sample collection for standard vaginal and labia-perineum samples and pH level information at the end of months three and six (both groups), or the same day as collecting your third extra labia-perineum sample (Group 2 only). The serum and shipping materials will be provided to you free of charge. Detailed instructions will be provided on how to apply the serum, and how and when to collect the samples. It is important that these are followed as carefully as possible.
For answers to frequently asked questions, click here.
Q: I have another health condition. Can I participate?
A: While certain conditions prevent participation in this study, participants with other health experiences may be eligible. We recommend completing the screening questionnaire to determine if you qualify. It’s very important for the success of the study that participant answers are accurate, so please provide any information you feel may be relevant.
Q: I am located outside of the UK. Can I participate?
A: Due to the logistics of shipping vaginal and labia-perineum samples, this study is only available to people based in the United Kingdom (including England, Wales, Scotland and Northern Ireland).
Q: Will I have to purchase any supplies or shipping labels to join this study?
A: If eligible for this study, it will not cost you any money to take part in this research.
All supplies needed will be posted to you at no cost, and shipping costs for posting your samples to the laboratory (Salient Labs Limited) will be covered by the research team. You will be provided with free returns labels and shipping materials in your sample collection kits.
Q: I need to change my delivery address. What should I do?
A: If your delivery address changes within the study duration, please notify us immediately by contacting serumstudy@liveutifree.com so that we can ensure your study materials are sent to the correct location.
Q: Is there a waiting list if the study becomes full?
A: Yes, we will leave the screening questionnaire open for a short period of time in order to create a waiting list. If you are added to the waiting list, you will receive an email to let you know once you have completed the screening questionnaire. In the event that a place in the study becomes available, we will get in touch with you by email.
Q: Are there any risks involved?
A: The B.Y.M. Microbiome Serum has been tested and approved for safety by three independent laboratories. The serum does not contain any ingredients that are prohibited for cosmetic use. The natural, live bacterium (Bdellovibrio bacteriovorus) has been tested and approved as safe for use on sensitive skin. There are no preservatives or fragrances in the serum. Each batch of the serum is also screened before sending to study participants to further ensure their safety.
Side effects are therefore not expected. However, if you experience any discomfort, potential side effects or have any concerns about using the B.Y.M. Microbiome Serum, please discontinue use immediately and contact the lead researchers via email as soon as possible: Dr Chiara Board at chiara@p-happi.com or Melissa Kramer at m.kramer@pgr.reading.ac.uk. You may also wish to seek medical advice from a GP or pharmacist, or contact your local emergency department. We have an internal study procedure related to side effects (or adverse events), so please let us know if this happens and continue to answer the questions about side effects in the weekly surveys.
Please note that the B.Y.M. Microbiome Serum is not a medical treatment and should not replace existing medications or health treatments.
Q: Are there any benefits involved?
A: By taking part in this study, you will be making an important contribution to our understanding of this new intimate health product and our insights into women’s health.
The B.Y.M. Microbiome Serum will be provided to you free of charge. In addition, to thank you for your involvement in this research, you will be provided with an online shopping voucher within three months of completing the six-month study.
Within three months of finishing collecting and analysing all the study data, we will also provide you with a summary report containing an anonymised overview of the vaginal and labia-perineum microbiome results from the study.
Q: Has ethical approval been received?
A: Yes, this study has been reviewed by the University Research Ethics Committee at the University of Reading, and has been given a favourable ethical opinion for conduct (2024-140-KF).
Q: Who can I contact if I have questions about the study?
A: Please use the below contact information:
Q: Why was I excluded?
A: Our research partners have outlined some criteria that determine if an individual may participate in this particular study. If you were excluded after completing the screening questionnaire, a list describing these criteria would have been displayed on the screen or sent to you by email. If you have additional questions, you can get in touch with the research team.
Even though you are unable to participate in the study, you can still help by referring others to participate. This research will benefit the entire community. The criteria for every study are different, so please don’t let this deter you from participating in other studies.
Q: If I am excluded from the study, can I request that my information be deleted?
A: Using a screening questionnaire of this type is a standard protocol for research and it has been approved by an ethics committee. If you do not qualify for this study, the information you provide will be stored until data collection for the study is finished and will then be deleted. Should you make a request prior to the study being finished, your data will be deleted.
Q: How will my data be stored and processed?
A: The organisations responsible for the protection of your personal and sensitive information are:
Queries regarding data protection and your rights should be directed in the first instance to B.Y.M. Technologies Ltd at chiara@p-happi.com, or in writing to: B.Y.M Technologies Ltd, C/O CMS CMNO LLP, Cannon Place, 78 Cannon Street, London, EC4N 6AF, United Kingdom.
Your data will be kept confidential and securely stored in a GDPR-compliant, password-protected folder only accessible by the research team. Your data will only be identified with a unique participant ID number, thus pseudonymising the data. Information linking that number to your name and any personal information will be stored securely and separately from the data you provide us. This separate file containing your name and personal information, and your consent form, will not be retained for longer than is necessary to complete the study and analyse the results, and will be subsequently deleted, but not earlier than five years. B.Y.M. Technologies Ltd will not have access to this file, and it will only be accessible by our research partner responsible for securely collecting and managing survey data (Live UTI Free Ltd and University of Reading). This will limit the transfer of personal information. Only your name and postal address, along with pseudonymised survey data, will be provided by Live UTI Free Ltd and University of Reading to B.Y.M. Technologies Ltd and Salient Labs Limited for the purposes of posting your serum bottles and sample collection kits, and to facilitate analysis. The non-personal data collected from this study will be preserved and made available in anonymised form, so that they can be consulted and re-used by others.
Under data protection law, we are required to inform you that our use of the personal data we may hold about you is on the lawful basis of being necessary for scientific research purposes. If you withdraw from a research study, which processes your personal data, depending on the stage of withdrawal, we may still rely on this lawful basis to continue using your data if your withdrawal would be of significant detriment to the research study aims. We will always have in place appropriate safeguards to protect your personal data.
What we use your personal information for | Lawful bases and conditions |
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Scientific research in the context of the research study | Lawful basis: For our legitimate interests in assessing the cosmetic ingredient. Condition (relevant for our processing of your health-related information and information that reveals race or ethnicity): For scientific research, in particular to determine if a new cosmetic ingredient can help protect and maintain a healthy female intimate external microbiome. The protection and maintenance of a healthy female intimate external microbiome being in the public interest. |
Respond to reports you may make of a possible side effect associated with application of the research study solution. | Lawful basis: To comply with our legal and regulatory obligations. Condition (relevant for our processing of your health-related information): Where necessary for reasons of public interest. |
To comply with demands or requests made by regulators, governments, courts and law enforcement authorities. | Lawful basis: To comply with our legal and regulatory obligations. Condition: Where necessary for reasons of public interest. |
Production of aggregated data | Lawful basis: For our legitimate interests in being able to use data in aggregated form for statistical analysis and to illustrate ingredient effects. Condition (relevant for our processing of your health-related information and information that reveals race or ethnicity): For scientific research purposes or statistical purposes. |
For the establishment, exercise or defence of legal claims | Lawful basis: For our legitimate interests in establishing, exercising, or defending legal claims. Condition (relevant for our processing of your health-related information and information that reveals race or ethnicity): For the establishment, exercise or defence of legal claims. |
We will need to share your personal information with others for the purposes outlined above and below, including:
You have certain rights under data protection law which are to:
Some restrictions apply to the above rights where data is collected and used for research purposes. You can find out more about your rights on the website of the Information Commissioner’s Office (ICO) at https://ico.org.uk. You also have a right to complain to the ICO if you are unhappy with how your data has been handled.