Changes in Colonic Microbiome With Fiber Supplementation
Summary
This clinical trial tests whether daily fiber supplementation will change the mucosal microbiome of the colon. The microbiome are microorganisms that live in the human gut. They serve a vital role in maintaining health. Certain microbial strains are associated with the growth of colon polyps, which eventually could go on to form colon cancer. Giving dietary fiber supplements may help prevent precancerous polyps from ever developing.
Detailed description
PRIMARY OBJECTIVE: I. To identify how diet, specifically fiber supplementation, alters the microbiome of the colonic mucosa. OUTLINE: Patients receive dietary fiber orally (PO) once daily (QD) for 28 days. Patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and at follow up or may undergo standard of care colonoscopy on study. All patients also undergo collection of blood samples on study and at follow up.
Arms & interventions
- Dietary SupplementDietary Fiber
Given PO
- ProcedureProctoscopy or anoscopy with Biopsy
Undergo proctoscopy or anoscopy
- ProcedureColonoscopy
Undergo Colonoscopy
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Change in microbiome colonic mucosa: taxa abundance
Will use data visualization techniques to understand the data and determine if microbiome count overall (richness) changes occur in patients who are started on fiber supplementation. In order to visualize overall changes after fiber supplementation, will generate plots showing relative abundance of the detected taxa for each subject at baseline and post-supplementation. For each taxa, will generate box plots to visually compare the median and interquartile range (IQR) of abundance between the two time points. Wilcoxon signed rank tests with an alpha level of 0.05 will determine if there is a difference in microbial derived short chain fatty acids after fiber supplementation in the blood and mucosa. Wilcoxon signed rank tests with an alpha level of 0.05 will determine if there is a difference in microbial derived short chain fatty acids after fiber supplementation in the blood and mucosa.
Time frame: Baseline and post-supplementation, up to 40 days
Change in microbiome colonic mucosa: microbiome diversity
Will use data visualization techniques to understand the data and determine if the types of metabolites (microbiome diversity) cases occur in patients who are started on fiber supplementation. In order to visualize overall changes after fiber supplementation. To assess for changes in microbiome diversity, our primary analysis will compare median Shannon diversity index values at baseline and post-supplementation. The Shannon index estimates diversity using richness and abundance. Will calculate Shannon index values for each participant at each time point and use a Wilcoxon signed rank test with an alpha level of 0.05 to determine if there is a difference in microbiome diversity after fiber supplementation.
Time frame: Baseline and post-supplementation, up to 40 days
Eligibility criteria
Study locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239