Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome

Study Overview
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Brief Summary
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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
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PRIMARY OBJECTIVE: I. To identify how diet, specifically fiber supplementation, alters the microbiome of the colonic mucosa. OUTLINE: Patients receive dietary fiber orally (PO) on study. Patients undergo proctoscopy or anoscopy with biopsy on study and during follow-up.

Official Title
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Changes in Colonic Mucosal Microbiome With Fiber Supplementation

Conditions
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Benign Colorectal Neoplasm, Non-Neoplastic Anal Disorder

Intervention / Treatment
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* Dietary Supplement: Dietary Fiber
* Procedure: Proctoscopy or anoscopy with Biopsy
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years Ability to understand and the willingness to sign a written informed consent document Patients who present with a chief complaint of a benign anorectal pathology including hemorrhoids, anal fissures, and anal fistulas without underlying conditions such as cancer or Crohn's disease Patients who had a colonoscopy within the past 2 years Exclusion Criteria: Patients with an active malignancy, Crohn's disease, ulcerative colitis, and immunosuppressed patients. Patients with hereditary colon cancer syndrome including Lynch syndrome or Familial Adenomatous Polyposis (FAP) Patients with a prior history of total or partial colon resection. Colorectal pathology such as polyps or cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (dietary fiber, proctoscopy or anoscopy with biopsy)<br>Patients receive dietary fiber PO on study. Patients undergo proctoscopy or anoscopy with biopsy on study and during follow-up. | Dietary Supplement: Dietary Fiber<br>* Given PO<br>* Other names: Fiber;Procedure: Proctoscopy or anoscopy with Biopsy<br>* Undergo proctoscopy or anoscopy<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, we will generate plots showing relative abundance of the detected taxa for each subject at baseline and post-supplementation. For each taxa, we will generate box plots to visually compare the median and interquartile range (IQR) of abundance between the two time points | 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. We 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. | Baseline and post-supplementation, up to 40 days |