AGDS-CellO – Microbiome Study PICF

Thank you for your interest in participating in this project. We will now begin the formalities of actively recruiting you into the project by collecting your personal details and obtaining your formal consent. The instructions below will walk you through the process for this formal consent.

Instructions:

1. Click on the title of each section to read the information required to participate.
2. Sections that are marked with ✅ must be read and agreed to by clicking the checkbox at the bottom of each.
3. Click on "I Agree and Wish to proceed" at the bottom of the page to consent to participate.
*Note: You will not be able to provide your consent unless you indicate your agreement to the sections marked.

Participant Information Sheet and Consent Form

Title	Investigating the Interaction Between Antidepressant Medication and the Gut Microbiome
Short Title	AGDS-CellO - Microbiome
Coordinating Principal Investigator	Professor Naomi Wray
Principal Investigator	Dr. Amedeo MiniChino
Location	The University of Queensland University of Oxford

1. Introduction

You are invited to take part in a research study Investigating the interaction between antidepressant medication and the gut microbiome. This form provides detailed information about the study to help you decide whether or not to participate.

The human gut is home to trillions of microorganisms, collectively known as the gut microbiome, which play a vital role in digestion, immune function, and overall health. In recent years, emerging research has highlighted the gut-brain axis - a complex communication network between the gut and the brain - suggesting that gut microbiota can influence mood, cognition, and mental health.

Antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants (TCAs), are commonly prescribed for depression and other mood disorders. While these medications primarily act on the brain's neurochemical pathways, evidence is growing that they may also impact the gut microbiome—potentially affecting treatment outcomes, side effects, and even individual responses to therapy.

However, current research on the interaction between antidepressants and the gut microbiome is limited and largely based on animal models or small-scale studies. Human-based data are urgently needed to understand how antidepressants may alter gut microbial composition and whether this plays a role in mental health outcomes or gastrointestinal side effects.

2. Purpose of the Study ✅

The primary purpose of this study is to investigate the potential relationship between antidepressant use and changes in gut microbiome composition in adults. By collecting a one-time stool sample and relevant background information from participants, we aim to:

Assess whether individuals taking antidepressant medications show distinct patterns in their gut microbiota compared to expected norms;
Explore how factors such as diet, supplement use, bowel habits, and medication history may influence this interaction;
Contribute to a growing body of knowledge that could help inform more personalized treatment approaches for mood disorders in the future.

This study is observational and exploratory in nature and is not intended to diagnose or treat any medical condition. However, its findings may pave the way for larger clinical studies and more integrated care approaches that consider both mental and gastrointestinal health.

This research is being undertaken by Professor Naomi Wray, the University of Queensland and Dr. Amedeo Minichino, The University of Oxford, England.

FS2 tickbox *

I have read and understood.

3. What Will Participation Involve? ✅

Consent

If you agree to participate, you will be asked to:

Complete an online questionnaire that includes sections on: dietary and bowel habits, current antidepression medication prescriptions and use and questions around gastrointestinal management and treatments.
Provide a one-off stool sample, collected using a provided collection kit.
Linage of information you have provided as part of your participation in the AGDS_CellO project.

You will receive all materials needed for sample collection and shipping. The process is designed to be hygienic, easy to follow, and respectful of your privacy.

Questionnaire

You will be asked to provide information about your diet over a one-week period and bowel habits, including its physical appearance. There are also questions around your current medication use and the dosage.

You will receive a unique research participant number and an electronic link from the Human Studies Unit (HSU) to complete the questionnaire online. This will take approximately 15 minutes to complete. Should you wish to complete a paper copy, we can provide this to you, or a member of the research team can administer this over the phone.

You will only need to complete the questionnaire once and you are not obliged to answer any questions that make you feel uncomfortable or questions you do not wish to answer. You can skip over them.

Biological Sample

If you consent to participate in this study, we will ask you to provide a stool (poo) sample. Your sample will be used in two ways:

To look at the type and number of different microbes that are found in your sample and
To test how your microbiome directly metabolises antidepressant medication and compare it to others who also have a depression diagnosis and are taking the same medication.

We will provide you with a collection kit and pre-labelled packaging to return the stool sample to the Human Studies Unit at the University of Queensland. At the end of the collection phase of this project all samples will be sent to The University of Oxford, England, United Kingdom.

This specialised work will require some of your stool sample to be send to the University of Oxford to the laboratory of Dr. Amedeo Minichino a collaborator of Professor Naomi Wray (Lead Investigator), The University of Queensland (UQ). Data will be generated from your samples that will be analysed with data from other individuals who have consented for this study. The data will be stored on secure servers at the University of Oxford under the direct supervision of Dr. Minichino for the period of this study and a copy will be shared with Professor Wray at UQ.
Your stool sample will be stored and used into the future with your consent. If you do not wish to have your biological samples and data generated from it available for further use in ethically approved studies you can indicate this on the consent form and the material will be disposed of after mandated time of retention of samples and data has passed, which is currently 7 years after the close of the project.

You may want to discuss your participation in this project with your family and other trusted individual before agreeing to participate in the project.

FS3 tickbox *

I have read and understood.

4. Confidentiality ✅

No identifiable personal information will be shared or stored with the sample or questionnaire.
You will be assigned a unique participant code that will be used to label both the stool sample and your questionnaire.
All data will be stored securely and accessed only by authorized members of the research team at the University of Oxford and UQ.

FS4 tickbox *

I have read and understood.

5. Risks of Participation ✅

The stool collection process may cause minor discomfort or inconvenience.
There is a small potential risk of accidental exposure to biological material during sample handling, though the provided kit is designed to minimize this risk.
There is no risk associated with the questionnaire other than potential mild discomfort in disclosing personal health information.

FS5 tickbox *

I have read and understood.

6. Benefits of Participation

There are no direct medical benefits to you for participating.
However, your participation will contribute to scientific knowledge that may help improve treatment for individuals using antidepressant medications.
You may also gain insights into your own bowel habits and medication use.

7. Voluntary Participation

If you decide to withdraw during the research project, we ask you to contact us via email: cello@uq.edu.au. Withdrawal from the study at any time will not affect your primary care delivered to you, in any way, or your relationship with the University of Queensland.

The research team will not collect additional personal information and your data will be removed and your biospecimens will be destroyed. Information already collected and included in analysis, will be retained to ensure research results are measured correctly and comply with law.

This research is conducted by Professor Naomi Wray and is funded by PI Wray’s NHMRC Investigator Grant: “Quantitative Genomics of Common Diseases” awarded in 2020.

You will not benefit financially from your involvement in this research project. In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to University of Queensland, there will be no financial benefit to you or your family.

8. Additional costs & reimbursement

There are no costs associated with participating in this research project. On completion of the questionnaire and once we have received your blood sample you will be given the option of receiving an electronic gift card to the value of $25 to your nominated email address for reimbursement of your time, and other expenses that you may have incurred as a result of participating. Or to donate all or some of the reimbursement back to the research should you wish to.

9. What Will Happen to the Results?

The results of this study may be published in scientific journals or presented at conferences. No individual participant will be identified in any report or publication.

10. Who has reviewed the research project?

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been approved by University of Queensland.

This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007) updated 2018. This statement has been developed to protect the interests of people who agree to participate in human research studies.

11. Further information and who to contact

The person you may need to contact will depend on the nature of your query. If you want further information concerning this project or if you have any medical problems which may be related to your involvement in the project, you can contact:

Research Project Manager contact

Name	Ms Anjali Henders
Position	Study Manager
Telephone	07 3346 2089
Email	a.henders@uq.edu.au

Research Genetic Counsellor

Name	Ms Leanne Wallace
Qualification	Master of Genetic Counselling
Email	hsu-projects@uq.edu.au

Reviewing HREC approving this research and HREC Executive Officer details

For matters relating to the online questionnaire troubleshooting or queries on biological samples, you can contact the HSU (Human Studies Unit) research staff:

Research staff contact

Name	HSU research staff
Telephone	07 3346 2089
Email	cello@uq.edu.au

If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact:

Reviewing HREC approving this research and HREC Executive Officer details

Reviewing HREC name	University of Queensland Human Research Ethics Committee
HREC Executive Officer	HREC Executive Officer
Telephone	07 3365 3924 / 07 34431656
Email	humanethics@research.uq.edu.au

✅ If You Are Ready to Proceed

If you have read and fully understood the information above, and you are ready to move on to the next part of the consent process, please click the button below.

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