Impact of Dietary Fiber Supplementation on Colonic Microbiome

OHSU Knight Cancer Institute

Status: Enrolling

Conditions: Benign Colorectal Neoplasm; Non-Neoplastic Anal Disorder

Treatments: Procedure: Proctoscopy or anoscopy with Biopsy; Dietary Supplement: Dietary Fiber; Other: Questionnaire Administration; Procedure: Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05643859

NCI-2022-07495 (Registry Identifier)

STUDY00024054 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Supportive care (oral fiber)

Experimental group

Description:

Patients receive dietary fiber orally (PO) on study. QD for 28 days. Patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and duringat 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.

Treatment:

Procedure: Colonoscopy

Other: Questionnaire Administration

Dietary Supplement: Dietary Fiber

Procedure: Proctoscopy or anoscopy with Biopsy