This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma. \- The name of the study drug involved in this study is: \-- AMR101 (VASCEPA).
This prospective, single-arm, research study evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma. * AMR101 is made of marine omega-3 fatty acid, which is a family of natural substances found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid cannot be produced in sufficient amount by the human body and has to be obtained through diet or supplemented to maintain normal function in the body. * The U.S. Food and Drug Administration (FDA) has not approved AMR101 as a treatment for any disease. * AMR101 is commercially available in the US as VASCEPA (icosapent ethyl) * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, including: * Lifestyle questionnaire, * Nutritional survey * Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample) * Blood samples, * AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will take part.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
81
AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in the Marine Omega-3 Polyunsaturated Fatty Acid (MO3PUFA) Composition in Colorectal Tissues as a Result of the AMR101 Treatment.
Measured using the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.
Time frame: 8-12 weeks
Change in the Gut Microbiome Composition
Measured using shotgun metagenomic sequencing of microbial DNA on pre- and post-treatment stool samples. The reported results represent the Shannon Diversity Index, which is a quantitative measure that reflects how many different bacterial species there are in a sample. The index's values range from 0 to 5, but usually range from 1.5 to 3.5. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity. We used the vegan R package to conduct the analysis.
Time frame: 8-12 weeks 8-12 weeks 8-12 weeks 8-12 weeks
Change in Fecal Metabolite Levels (Butyrate)
Butyrate is the metabolite of our most interest for the current study, based on the prior data suggesting that marine omega-3 fatty acid may increase the production of butyrate by bacterial fermentation of dietary fiber. The metabolites were measured by the non-targeted global metabolomic panel. The measurement represents the abundance (assessed as weight percentage of density) of a metabolite after total-signal normalization to account for varying water weight across stool samples.
Time frame: 8-12 weeks
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