This trial studies if increasing the amount of fiber that people eat will change the bacteria that live in the colon and change how those bacteria affect the cells in the colon that can cause colon cancer. Alaska Native people have very high rates of colon cancer. Fiber is a carbohydrate that comes from plants and is not digested by the human body. Fiber that is not broken down, also called cellulose, promotes colon health and normal stool (feces) formation, which helps to prevent diarrhea and constipation. Resistant starches are carbohydrates that behave like fiber in the diet because they are not fully digested like other starches. Resistant starches are fermented by bacteria in the colon, where some healthy nutrients are produced. These resistant starches are thought to promote a healthy and thriving population of beneficial gut bacteria. Comparing volunteers who supplement their usual diet with resistant starch to volunteers who supplement their usual diet with digestible starch may help to see if there are any differences in colon cells between the two groups.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03028831.
PRIMARY OBJECTIVES:
I. Determine if high fiber feeding can induce clinically meaningful (20%) reduction from baseline in colonic mucosal Ki67.
II. Investigate hypothesis that the extreme risk of colon cancer in Alaska native (AN) is a consequence of a relative butyrate deficiency in the setting of high carcinogen exposure, using the data collected during the randomized controlled trial (RCT) in specific aim (SA)1 to:
IIa. Determine whether ‘responders’ to fiber supplementation had increased fecal and colonic butyrate producers and butyrate content and reduced secondary bile acid producers and content.
OUTLINE: Participants undergo standard of care colonoscopy and are randomized to 1 on 2 arms.
Arm I: Between 8 and 12 weeks after colonoscopy, participants receive resistant starch orally (PO) daily for 4 weeks.
Arm II: Between 8 and 12 weeks after colonoscopy, participants receive digestible starch PO daily for 4 weeks.
After completion of study, participants are followed up on days 7, 14, and 21.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorStephen J. O'Keefe
