Persephone Biosciences Announces Topline Results from AMBROSIA Food as Medicine Study with Kroger Health
- AMBROSIA is the largest study to evaluate the impact of Medical Nutrition Therapy (MNT) on diet quality and the gut microbiome, with 546 participants enrolled -
- Topline results from the study identified three enterotypes, one of which was associated with increased BMI and poorer diet, and demonstrated that MNT can successfully improve microbiome composition and enable patients to switch enterotypes -
- The U.S.-based study was run in collaboration with Kroger Health, the healthcare division of The Kroger Co -
SAN DIEGO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Persephone Biosciences, a pioneering biotech company focused on unlocking the potential of the microbiome to impact human health, today announced topline results from its AMBROSIA Food as Medicine clinical study (NCT06091813), which was run in collaboration with Kroger Health to investigate how the microbiome is impacted by diet and lifestyle factors. Topline results from the study identified three enterotypes, one of which was associated with increased BMI and poorer diet and demonstrated that Medical Nutritional Therapy (MNT) can successfully improve microbiome composition, enabling subjects to switch enterotypes.
“We’re thrilled to have completed the AMBROSIA study, the largest study to evaluate the impact of Medical Nutrition Therapy on diet quality and the gut microbiome. I would like to express my deep gratitude to the participants, and to Kroger Health for joining with us in this groundbreaking study,” said Stephanie Culler, CEO and Co-founder of Persephone Biosciences. “While the role of gut microbes in human health, and the impact of diet on microbiome composition, has been recognized for decades, today’s study finally brings us closer to understanding that complex interaction.”
Culler continued: “In the AMRBOSIA study, we were able to demonstrate that Medical Nutrition Therapy can help patients rebuild and improve their microbiome composition by switching enterotypes, which could in turn lead to better health outcomes. Further research could validate this and unlock opportunities to offer testing options at retail to support customers’ health and wellness journeys.”
AMBROSIA is the largest study to date evaluating the impact of MNT on diet quality and the gut microbiome. 546 participants aged between 18-64 years old at high risk of colorectal cancer (CRC) were enrolled in the study. Subjects were allowed to enroll if they have had previous colonoscopy findings, were in remission from CRC, or if they had any of the following three conditions: they were obese or overweight; a parent or sibling had developed colon cancer; or they had been a smoker for 10 or more years.
Subjects were randomized across two arms in equal number. Subjects in the first cohort underwent MNT for a period of 4 months, while subjects in the second cohort received no directed dietary modifications and are referred to as the control group. Microbiome composition and diet score were evaluated at baseline and again after 4 months.
Results
- Microbiome analysis indicates that participants fall into one of three general categories (enterotypes), each of which is characterized by a high concentration of different bacterial species.
- Enterotype 3, which is dominated by the genus Prevotella, was found to be associated with higher body mass index (BMI), lower diet score, and lower microbial diversity.
- At four months, the MNT cohort had higher final diet scores and higher movement between enterotypes than the control cohort.
- Furthermore, the study found that the number of MNT visits and the percentage of goals attained were found to be directly correlated with diet score.
- Functional analysis also demonstrated that each enterotype is enriched in gene functions enabling consumption of a particular type of fiber. Based on this, Persephone hypothesizes that no enterotype is inherently unhealthy, but rather that each enterotype is best suited for a particular diet.
- Importantly, these findings point to benefits of incorporating MNT, coupled with microbiome analysis, into personalized nutrition, to potentially lead to better health outcomes.
“Kroger Health is excited to share topline results from the AMBROSIA study, alongside Persephone Biosciences, an investment we made as part of our commitment to advancing Food as Medicine as one of our health initiatives,” said Jim Kirby, Chief Commercial Officer, Kroger Health. “Having demonstrated the positive benefits to the microbiome of providing one-on-one virtual nutrition coaching visits, we would love to use this information to unlock new avenues for personalized healthcare and, potentially, improved well-being for all.”
According to the CDC, colorectal cancer is one of the leading killers 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 additionally be used to assess the extent to which this is true.
About Persephone Biosciences
Persephone is a pioneering biotech company reimagining infant and patient health using rigorous clinical research to unlock the potential of the gut microbiome to prevent and treat disease. Persephone is backed by notable investors including Y Combinator, Fifty Years, Susa Ventures, American Cancer Society’s BrightEdge Fund, Pioneer Fund, First Bight Ventures, Propel Bio Partners, Ocampo Capital, Mesa Verde Partners and Capita3. Our My Baby Biome study uncovered the widespread gaps in modern infant gut health. Learn more at www.persephone.bio.
Investor Contact
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