Colon Cancer Clinical Trial

Impact of Dietary Fiber Supplementation on Colonic Mucosal Microbiome

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.

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Full 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.

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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 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

Study is for people with:

Colon Cancer

Estimated Enrollment:

120

Study ID:

NCT05643859

Recruitment Status:

Recruiting

Sponsor:

OHSU Knight Cancer Institute

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There is 1 Location for this study

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OHSU Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Vassiliki L. Tsikitis, M.D.
Contact
503-494-1735
[email protected]
Vassiliki L. Tsikitis, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

120

Study ID:

NCT05643859

Recruitment Status:

Recruiting

Sponsor:


OHSU Knight Cancer Institute

How clear is this clinincal trial information?

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