Impact of Dietary Fiber Supplementation on Colonic Microbiome

Conditions

• Benign Colorectal Neoplasm
• Non-Neoplastic Anal Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dietary Fiber — DIETARY_SUPPLEMENT
  Given PO
• Proctoscopy or anoscopy with Biopsy — PROCEDURE
  Undergo proctoscopy or anoscopy
• Colonoscopy — PROCEDURE
  Undergo Colonoscopy
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Apr 1, 2023

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

120 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Supportive care (oral fiber)
  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.

Primary Outcome Measure

Change in microbiome colonic mucosa: taxa abundance [ Time Frame: Baseline and post-supplementation, up to 40 days ]

Central Contacts

• Shahrose Rahman, M.D.
  503-494-8652
  [email protected]
• Amber O'Connor
  [email protected]

Locations (1)

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