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Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome

Sponsor
OHSU Knight Cancer Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05643859
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
6
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary Fiber
  • Procedure: Proctoscopy or anoscopy with Biopsy
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Changes in Colonic Mucosal Microbiome With Fiber Supplementation
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive care (dietary fiber, proctoscopy or anoscopy with biopsy)

Patients receive dietary fiber PO on study. Patients undergo proctoscopy or anoscopy with biopsy on study and during follow-up.

Dietary Supplement: Dietary Fiber
Given PO
Other Names:
  • Fiber

    • Procedure: Proctoscopy or anoscopy with Biopsy
    Undergo proctoscopy or anoscopy

    Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in microbiome colonic mucosa: taxa abundance [Baseline and post-supplementation, up to 40 days]

      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

    2. Change in microbiome colonic mucosa: microbiome diversity [Baseline and post-supplementation, up to 40 days]

      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 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OHSU Knight Cancer Institute Portland Oregon United States 97239

    Sponsors and Collaborators

    • OHSU Knight Cancer Institute

    Investigators

    • Principal Investigator: Vassiliki L Tsikitis, M.D., OHSU Knight Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vassiliki Tsikitis, Principal Investigator, OHSU Knight Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05643859
    Other Study ID Numbers:
    • STUDY00024054
    • NCI-2022-07495
    • NCI-2022-05415
    • STUDY00024054
    First Posted:
    Dec 9, 2022
    Last Update Posted:
    Dec 9, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Dec 9, 2022