Persephone Biosciences, a biotechnology company reimagining patient health through the development of microbiome-based products, today announced that the last patient has enrolled in its AMBROSIA Food as Medicine clinical study, which is being facilitated in collaboration with Kroger Health, the healthcare division of The Kroger Co. to study how the microbiome is impacted by diet and lifestyle factors.
“We’re delighted to have enrolled the last participant in our AMRBOSIA study, which represents an important milestone for Persephone Biosciences and our collaborator, Kroger Health,” said Stephanie Culler, CEO and Co-founder of Persephone Biosciences. “Having established baseline data for our subjects, we are now keen to assess the effect of Medical Nutrition Therapy and associated diet quality changes on the gut microbiome. The role of gut microbes in human health and the impact of diet on the microbiome composition has been recognized for decades, but the specific impact of diet quality and lifestyle behaviors are only beginning to be understood.”
Culler continued: “The efficient execution of this study to date – which I believe positions Persephone as the future partner of choice for similar future clinical studies – is a testament to the quality infrastructure, protocols and know-how we have built. I would like to thank all the participants enrolled in our study, as well as both teams, for helping us reach today’s important landmark.”
The AMBROSIA study has enrolled 400 participants aged 18-64 years old, who are considered to be at medium-to-high risk of developing colorectal cancer (CRC). Subjects are allowed to enroll if they have had previous colonoscopy findings, are in remission from CRC, or if they have at least two of the following three conditions: they are obese or overweight; a parent or sibling has had colon cancer; or they have been a smoker for 10 or more years.
Subjects have been allocated across two arms:
- Participants in the first cohort receive no directed dietary modifications and are referred to as the control group (n=200).
- Participants in the second cohort receive Medical Nutrition Therapy (MNT) in the form of dietitian-led virtual nutrition counseling with a Kroger Health registered dietitian (n=200).
According to the Centers for Disease Control & Prevention (CDC), colorectal cancer is one of the leading causes of death in the U.S., of cancers that affect both men and women. Approximately nine out of ten people whose colorectal cancers are found early and treated appropriately are still alive five years later. A growing body of evidence shows the bacteria living in the gut may influence an individual’s risk of developing colorectal cancer; the data collected from the AMBROSIA trial will be used to assess the extent to which this is true, and how MNT could be used to as a preventative strategy. Persephone expects to publish findings from this study in H2 2025.
