GENERAL INFORMATION

What is the goal of the FAMiLI Study?

We hope to improve our understanding of how the human microbiome and diet relate to various diseases such as cancer, heart disease, and diabetes. Having a better understanding of the human microbiome allows us to understand disease and disease progression, and will lead to new ways to prevent diseases.

What does “human microbiome” mean?

The “human microbiome” refers to the 10-100 trillion microorganisms living in and on the human body, including bacteria and viruses. Microbes living in the mouth are called the “oral microbiome” and those in the gut are called the “gut microbiome.” You can find out more about the microbiome HERE.

How is this study being funded?

The FAMiLI Study is funded by the NYU School of Medicine Department of Population Health and the NYU Langone Perlmutter Cancer Center.

Can I participate?

You are eligible to participate in this study if you are:

1. 40 years old, or older;
2. Not currently pregnant; and
3. Not currently on ongoing antibiotic therapy.

How do I participate? What can I expect once I sign up?

Once you register online or in person, you will:

1. Receive a kit with all the materials you will need.
2. Sign the informed consent form, follow the instructions to collect your mouthwash and stool samples, and fill out the two questionnaires (note: you may also fill out the questionnaires online.
3. Keep one copy of the informed consent form for yourself, and drop off the completed Participant Kit with the 5 required materials (1 consent form, 1 mouthwash sample, 1 stool sample, 1 demographic questionnaire, 1 diet questionnaire) at any USPS box (prepaid postage is included).

When the FAMiLI Study team receives all 5 required materials (questionnaires may be returned in paper form or filled out online), your $25 gift card will be activated for your use.

What materials are provided in the kit?

1. Informed consent forms (2 copies)
2. Demographic questionnaire
3. Diet questionnaire
4. Oral sample kit
1. Mouthwash (Scope)
2. Tube with blue cap
3. Plastic specimen bag to hold your completed mouthwash sample (absorbent materials included in case of spills)
5. Stool sample kit
1. Stool collection paper
2. Pair of gloves
3. Tube with green cap containing preservation liquid
4. Plastic bag to hold your completed stool sample (absorbent materials included in case of spills)

Will you be collecting my blood?

No. We will only collect your oral and stool samples.

How will my samples be used?

Your samples will be analyzed at a laboratory at the NYU Grossman School of Medicine. The lab will explore how bacteria (human microbiome) living in the mouth and gut relate to various diseases.

Do I have to do anything else after I complete the Participant Kit?

The Participant Kit is the majority of the involvement in this study. In the future, we will send a brief questionnaire that will take about 2-3 minutes to complete, in order to check in with you regarding any potential health changes.

Can family members or other people I know participate in the study?

Yes! If you know anyone who is interested in participating, or would like to find out more about the study, you can refer them via email (famili@nyumc.org) or on our website (http://www.nyufamili.org/).

ABOUT THE KIT

What is the informed consent form? Why do I need to sign it?

The informed consent form describes what the study is about, and what your participation would involve. Signing the informed consent form means that you agree to participate as a volunteer. After signing the form, you are free to withdraw from the study at any time.

Where can I access the questionnaires online?

You can fill out the questionnaires online at this link: www.nyufamili.org/questionnaire.

How long do the questionnaires take to complete?

It takes about 45 minutes to complete both questionnaires. You do not have to complete these at the same time, and you do not have to do them all at once.

Do I have to complete the questionnaires at one time?

No, you can complete the questionnaire at your own pace. On the online questionnaire, you can save what you’ve completed, and return at any time. You will receive a keycode via email, and this is the code you will input to return to your survey.

When should I send the kit containing my samples, questionnaires, and informed consent?

To ensure accurate tests, please mail back the kit within 24 hours of collecting the samples.

Can I keep my normal diet and take any prescription medications/vitamins/supplements?

Yes. However, if you are currently on antibiotics temporarily (ex: after surgery), please contact us.

When should I collect the samples?

You can collect the samples at any time of the day at your convenience.

I read the Booklet instructions, and I have a few questions.

If you have any questions, please call (212) 263-6838 and we are happy to answer any questions.

TROUBLESHOOTING

I spilled some of the preservation liquid in the stool sample kit. What should I do?

Please contact us.

I forgot to send my kit on time (24 hours after stool sample collection). What should I do?

Please contact us.

Thank you for your participation! If you have any additional unanswered questions, please contact us for assistance.