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NCT05643859NARecruiting

Impact of Dietary Fiber Supplementation on Colonic Microbiome

OHSU Knight Cancer Institute

Start Date

4/1/2023

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 colorectal 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 cancer or proctitis, after initial study scope

Interventions

DIETARY_SUPPLEMENT

Dietary Fiber

PROCEDURE

Proctoscopy or anoscopy with Biopsy

PROCEDURE

Colonoscopy

OTHER

Questionnaire Administration

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Conditions

Benign Colorectal NeoplasmNon-Neoplastic Anal Disorder

Locations

OHSU Knight Cancer Institute

Portland, Oregon 97239

United States