Persephone Biosciences Completes Enrollment for Landmark Microbiome-Diet Study in Colorectal Cancer Prevention
Key Insights
Persephone Biosciences (search) has successfully enrolled 400 participants at medium-to-high risk of colorectal cancer (search) in their AMBROSIA (search) study, investigating the relationship between diet quality and gut microbiome composition.
The study includes two cohorts: a control group and an intervention group receiving Medical Nutrition Therapy through Kroger Health (search) registered dietitians, with results expected in H2 2025.
This research aims to understand how dietary interventions may influence colorectal cancer (search) risk through microbiome modulation, addressing a leading cause of cancer deaths in the United States.
In a significant advancement for microbiome research, Persephone Biosciences (search) has announced the completion of enrollment for its AMBROSIA (search) Food as Medicine clinical study. The study, conducted in collaboration with Kroger Health (search), has successfully recruited 400 participants to investigate the complex relationship between diet, gut microbiome composition, and colorectal cancer (search) risk.
Study Design and Population
The AMBROSIA (search) study focuses on individuals aged 18-64 who face medium-to-high risk of developing colorectal cancer (search). Participants qualify based on previous colonoscopy findings, CRC remission status, or the presence of at least two risk factors including obesity/overweight status, family history of colon cancer, or extended smoking history.
The study population is equally divided into two cohorts of 200 participants each. The control group will maintain their regular dietary habits, while the intervention group will receive specialized Medical Nutrition Therapy (MNT) through virtual consultations with Kroger Health (search) registered dietitians.
Clinical Significance
"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," stated Stephanie Culler, CEO and Co-founder of Persephone Biosciences (search). She emphasized that while the connection between gut microbes and human health has been recognized for decades, the specific impacts of diet quality and lifestyle behaviors are still being uncovered.
The research addresses a critical public health concern, as colorectal cancer (search) remains one of the leading causes of cancer-related deaths in the United States affecting both men and women, according to the Centers for Disease Control & Prevention (search). Early detection and treatment significantly improve survival rates, with approximately 90% of patients surviving five years post-diagnosis when the cancer is caught early.
Future Implications
The AMBROSIA (search) study represents a crucial step in understanding how dietary interventions might be leveraged for cancer prevention through microbiome modulation. This research could potentially inform future preventative strategies and dietary recommendations for individuals at risk of colorectal cancer (search).
Persephone Biosciences (search) plans to publish the study findings in the second half of 2025. The successful enrollment completion demonstrates the company's capability to execute complex clinical studies, positioning it as a potential partner for future microbiome-related research initiatives.