Most humans have gut bacteria that transform cholesterol into a molecule called coprostanol, which is excreted in feces more easily than cholesterol. This helps the body get rid of excess cholesterol, and evidence suggests that these bacteria play an important role in preventing the buildup of cholesterol plaques in our blood vessels. However, not all people have these bacteria in their gut. Existing research indicates that roughly one in five individuals lack coprostanol-producing gut bacteria--likely due to prior antibiotic use--and this absence may be associated with high blood cholesterol levels and heart disease risk.

Stephen Skolnick and Company, doing business as Constellation Bio (“we” or “the company”), is undertaking a study to better understand the relationship between bacterial coprostanol production in the gut and serum cholesterol. Specifically, we will be assessing levels of cholesterol and coprostanol in participants’ feces, and comparing this to their serum lipid profile. This will involve chemical analysis to determine the relative amounts of cholesterol and coprostanol in stool, and potentially microbiological analysis to better understand which kinds of gut bacteria are responsible for coprostanol production.

To make this work possible, we are collecting small (milligram-scale) fecal samples from a diverse group of adult volunteers, along with certain data around cardiovascular health.

Terms of Participation, Risks and Potential Benefits

If you are a US resident over the age of 18 years old, have had your cholesterol levels tested in the past year, and are willing to share the results of that test, you are invited to participate. If you choose to participate, you will collect a sample in your own bathroom, at your leisure, using materials we provide. Sampling is simple and completely noninvasive, and for this reason we anticipate no physical risks associated with participation in this research (see kit instructions for more information).

You may choose whether or not we contact you in the future regarding your participation in this study. If you do not wish to be contacted, your involvement with this research will end when you provide us with your sample. However, declining to be contacted limits the extent to which you may benefit from participating in this study.

If you consent to be contacted, we will share any data generated from your sample with you, including fecal cholesterol/coprostanol levels, microbiome composition, etc.—and how these relate to the corresponding features of our study population overall, along with our interpretations of these findings. This may turn out to be important health information.

Additionally, this study is part of a broader program to develop a probiotic which restores the capacity to convert cholesterol to coprostanol in people missing this capability; if your results indicate that you are missing this capability, and you agree to further contact, we may reach out to recruit you for an interventional trial of this microbe, in hopes that it can lower cholesterol and reduce the risk of heart attack, stroke, etc.

In any case, we will never publish, sell, or share identifying information associating you with your sample. If you consent to be contacted, we will only discuss your results with you directly, at the phone number or email address you provide, unless you instruct us otherwise. We will take all reasonable precautions with your personal and health data, but taking part in this study may present a risk of having such information exposed in the event e.g. of a data breach or unauthorized access to your email account.

By agreeing to participate and providing a sample, you relinquish any control over, or rights to, the biological material or information derived from your sample, including rights to remuneration from the company. You further acknowledge that we may use these materials and data (except personal data), in this and any future projects, for any purpose we see fit, without restriction and in perpetuity, and may likewise transfer or assign these samples and associated information to any affiliates or third parties.

Understanding and Consent

Participation in this project is entirely voluntary. If at any time, for any reason, you are unable or unwilling to complete a donation, you are under no obligation to continue with the process. If any of the terms laid out here are unacceptable, or if you anticipate unusual psychological distress or anxiety from the donation process as described above, please simply do not enroll, or else inform staff that you do not wish to participate.

If you have questions, please reach out to our staff at ConstellationBio@gmail.com before continuing further; by filling out and submitting this form, you indicate your understanding and acceptance of the risks and other terms described above.