Back to resultsImpact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome
Primary Purpose
Benign Colorectal Neoplasm, Non-Neoplastic Anal Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Fiber
Proctoscopy or anoscopy with Biopsy
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Benign Colorectal Neoplasm
Eligibility Criteria
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
Sites / Locations
- OHSU Knight Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (dietary fiber, proctoscopy or anoscopy with biopsy)
Arm Description
Patients receive dietary fiber PO on study. Patients undergo proctoscopy or anoscopy with biopsy on study and during follow-up.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05643859
First Posted
September 26, 2022
Last Updated
April 18, 2023
Sponsor
OHSU Knight Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05643859
Brief Title
Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome
Official Title
Changes in Colonic Mucosal Microbiome With Fiber Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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) on study. Patients undergo proctoscopy or anoscopy with biopsy on study and during follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Colorectal Neoplasm, Non-Neoplastic Anal Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (dietary fiber, proctoscopy or anoscopy with biopsy)
Arm Type
Experimental
Arm Description
Patients receive dietary fiber PO on study. Patients undergo proctoscopy or anoscopy with biopsy on study and during follow-up.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Fiber
Other Intervention Name(s)
Fiber
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
Proctoscopy or anoscopy with Biopsy
Intervention Description
Undergo proctoscopy or anoscopy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in microbiome colonic mucosa: taxa abundance
Description
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
Time Frame
Baseline and post-supplementation, up to 40 days
Title
Change in microbiome colonic mucosa: microbiome diversity
Description
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.
Time Frame
Baseline and post-supplementation, up to 40 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahrose Rahman, M.D.
Phone
503-494-8652
Email
rahmasha@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amber O'Connor
Email
oconnoam@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vassiliki L Tsikitis, M.D.
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vassiliki L. Tsikitis, M.D.
Phone
503-494-1735
Email
tsikitis@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Vassiliki L. Tsikitis, M.D.
12. IPD Sharing Statement
Learn more about this trial
Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome
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