Join The Digital Microbiology Healthy Urogenital Biome Study
Do you want to find out what’s in your bladder? So do we!
In 2014, it was discovered that urine is not sterile, meaning that multiple living organisms reside in the bladder of most, if not all, people.
More recently, an interconnection between the urinary and vaginal microbiomes was established. We call these overlapping microbiomes the urogenital biome.
More specifically, the urogenital biome refers to the community of microorganisms, including bacteria, fungi, and viruses, that live in the urinary and genital tracts. These microorganisms play an important role in maintaining health by protecting against infections and supporting normal bodily functions.
Researchers have a lot of catching up to do in order to learn what healthy urinary and vaginal microbiomes look like, and how they impact one another. For this reason, we’re collaborating with Digital Microbiology on research into the healthy female urogenital biome.
The purpose of this study is to gain a better understanding of what organisms are present in a healthy female urogenital biome and how this might differ between age groups.
Are you ready to contribute to science?
UK-based participants that meet the following criteria:
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- Assigned female at birth
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- At least 18 years old
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- Not currently pregnant
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- Willing and able to collect and return by post two vaginal swab samples, a vaginal pH test and a urine sample (postage costs will be paid for you)
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.
What does study participation require?
Participants can complete this entire study from their own home. If you are eligible and consent to participate you will be asked to complete a series of two online surveys and provide two vaginal swab samples, a vaginal pH test result, and a single urine sample.
The first online survey will include questions about demographics, your health history, and your postal address for the purpose of shipping your sample collection kit. Your sample collection kit will then be sent to you free of charge by post, directly from SBL.
The second online survey will ask a series of questions about any symptoms you are experiencing on that day, and about any medications you have taken, along with an optional section about sexual activity. The second survey would be completed on the day that you collect your vaginal swab samples, vaginal pH test, and a urine sample. Detailed instructions will be provided regarding how to collect your samples. Free return shipping materials will be included with the sample collection kit. The samples can be returned via a Royal Mail postbox.
Taking part in this study is completely voluntary; you may withdraw at any time without having to give any reason. Please feel free to ask any questions that you may have about this study at any point by contacting the research team.
To see if you might qualify for this study, we need to ask you some questions about your health history and current health status, via a screening questionnaire. Please be aware that answering yes to some of these questions does not necessarily exclude you from participation, but the information we collect is important for the study itself. See more information about the study on the screening questionnaire.
Those who qualify for the study will be sent further information about participation requirements by email, and will then have the opportunity to decide whether they would like to participate. Those who do not qualify will be informed of this at the end of the screening questionnaire.
Completing the screening questionnaire does not represent a commitment to join the study and it is possible to withdraw interest at any time.
Will I find out what’s in my biome?
Who is Digital Microbiology?
Frequently Asked Questions
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: If you are not based in the UK (England, Wales, Scotland and Northern Ireland), you are not eligible to participate. This restriction aims to minimise potential geographic effects of urogenital microbial composition, and the study will focus on residents of the United Kingdom only.
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 will be covered by the research team. You will be provided with free returns labels and shipping materials in your sample collection kit.
Q: I need to change my email or delivery address. What should I do?
A: If your delivery address changes before you receive your study kit, please notify us immediately by contacting [email protected] so that we can ensure your study materials are sent to the correct location. If your email address changes at any time during the study, please notify us immediately by contacting [email protected].
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: Some people may find that answering questions about their personal experience induces negative feelings, which may include anxiety, anger or other emotional responses. It is also possible that some people may find it uncomfortable to collect a urine sample, or to collect vaginal swab samples which require inserting a swab into the vagina. Full instructions on how to collect samples will be provided to participants, to assist with this process. If you are concerned about any of the questions in the study, or the participation requirements then you may choose to discontinue your participation at any time without having to provide any reason.
Q: Are there any benefits involved?
A: Within one week of the return of their vaginal swab and urine samples, each participant will receive a digital report outlining the organisms found in each sample. This report will contain reference information about microorganisms identified. The report is not intended to be used for diagnostics purposes and the SBL team will not be able to provide any additional support for interpretation of the report. We hope the report will provide interesting insights for those curious about microbiome science!
By taking part in this study, you will also be making an important contribution to our understanding of the healthy female urogenital biome, and furthering our insights into women’s health. This will in turn aid in the identification and understanding of how and when things change to lead to symptoms for those who experience recurrent or chronic UTI.
Q: Has ethical approval been received?
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Q: Who can I contact if I have questions about the study?
A: Please use the below contact information:
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- General questions about the study, online surveys, and shipping information (including tracking and returns): [email protected]
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- Questions specifically related to how to collect the required vaginal swab and urine samples: [email protected]
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- Questions regarding the online portal for kit registration and collection day survey: [email protected]
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- General questions about ethical approval or the University of Reading's oversight of the study can be directed to the Chief Investigator, Dr Katherine Finlay using the research team email address above.
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: Who will have access to my data?
A: The organisations responsible for the protection of your personal and sensitive information are:
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- Live UTI Free Ltd
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- Systems Biology Laboratory UK c.i.c.
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- University of Reading
Queries regarding data protection and your rights should be directed in the first instance to Live UTI Free Ltd: [email protected]
Queries regarding data protection and the Digital Microbiology online portal should be directed to: [email protected]
Queries regarding data protection supervision by the University of Reading should be directed to: [email protected]
Further information about data storage and processing throughout participation in the study will be provided in the participant information sheet prior to participation consent.
You have certain rights under data protection law which are to:
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- Withdraw your consent, for example if you opted in to be added to a participant register,
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- Access your personal data or ask for a copy,
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- Rectify inaccuracies in personal data that we hold about you,
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- Be forgotten, that is your details to be removed from systems that we use to process your personal data,
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- Restrict uses of your data, and
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- Object to uses of your data, for example retention after you have withdrawn from a study.
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.