Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome

Benign Colorectal Neoplasm Clinical Trial

Official title:

Changes in Colonic Microbiome With Fiber Supplementation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05643859
• Other study ID #: STUDY00024054
• Secondary ID: NCI-2022-07495NC
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: OHSU Knight Cancer Institute
• Contact: Shahrose Rahman, M.D.
• Phone: 503-494-8652
• Email: rahmasha[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 or are undergoing a standard of care colonoscopy procedure

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

Related Conditions & MeSH terms

• Benign Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Dietary Fiber
Given PO

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

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and post-supplementation, up to 40 days
Primary	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.	Baseline and post-supplementation, up to 40 days