Evaluating the effects of dietary changes on gut health

Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism

This study is testing if changing what you eat, with help from nutrition experts, can improve gut health in adults at high risk for colorectal cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Persephone Biosciences (industry)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06091813 on ClinicalTrials.gov

What this trial studies

This study aims to determine how modifications in dietary behavior, guided by medical nutrition therapy, affect diet quality and the composition of the gut microbiome. It will involve 400 adults aged 18-64 who are at high risk for colorectal cancer, divided into two groups: one receiving nutrition counseling and the other serving as a control. Participants will provide stool samples for analysis before and after the intervention, with assessments including whole genome sequencing and metabolite profiling. The study seeks to understand the relationship between diet and gut health through a structured approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 at high risk for colorectal cancer due to personal or family history, obesity, or long-term smoking.

Not a fit: Patients without risk factors for colorectal cancer or those unable to participate in dietary modifications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dietary recommendations that enhance gut health and reduce colorectal cancer risk.

How similar studies have performed: Previous studies have shown promising results in dietary interventions impacting gut microbiome health, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Adults 18 to 64 years old at the time of enrollment at high risk for colorectal cancer, defined as follows:

   1. EITHER a personal history of colorectal cancer, advanced adenoma, or 3 or more non-advanced adenomas in a single screening
   2. OR TWO of the following criteria:

      * One or more first-degree relatives with a history of colorectal cancer
      * Body mass index above 30 (Persephone will calculate given height and weight
      * Have smoked an average of 5 or more cigarettes (1/4 pack) per day for a continuous period of 10 years or more.
2. Able to provide stool samples at study start and after approximately 5 months
3. Willing and able to undergo virtual Medical Nutrition Therapy based on cohort assignment
4. Willing to complete online questionnaires concerning diet and lifestyle, in English
5. Competency in spoken and written English
6. Can provide written informed consent

Exclusion Criteria:

1. Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C
2. Known Familial Adenomatous Polyposis or Lynch Syndrome (aka Hereditary Non-Polyposis Colorectal Cancer or HNPCC) diagnosis
3. A history of Crohn's Disease, Inflammatory Bowel Disease, or chronic colitis.
4. Active cancer in the past 2 years, or currently undergoing any form of cancer therapy.
5. Confirmed case of COVID-19 or influenza within one month prior to enrollment
6. Oral or systemic antibiotic or probiotic use, or a known GI infection, within 3 months prior to enrollment
7. Engaged in a nutritional or dietary intervention in the past 3 months.
8. Women who are pregnant or plan to become pregnant in the next 6 months, or currently nursing.

Where this trial is running

San Diego, California

• Persephone Biosciences, Inc. — San Diego, California, United States (RECRUITING)

Study contacts

• Principal investigator: Charles Baum, MD — Independent
• Study coordinator: Stephen Van Dien, PhD

Conditions: Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition