NCT05643859

Impact of Dietary Fiber Supplementation on Colonic Microbiome

Changes in Colonic Microbiome With Fiber Supplementation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Colorectal Neoplasm
• Non-Neoplastic Anal Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Fiber	Given PO
PROCEDURE	Proctoscopy or anoscopy with Biopsy	Undergo proctoscopy or anoscopy
PROCEDURE	Colonoscopy	Undergo Colonoscopy
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-12-09
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States