Impact of Dietary Fiber Supplementation on Colonic Microbiome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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

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Benign Colorectal Neoplasm Non-Neoplastic Anal Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dietary Fiber

Intervention Type DIETARY_SUPPLEMENT

Given PO

Proctoscopy or anoscopy with Biopsy

Intervention Type PROCEDURE

Undergo proctoscopy or anoscopy

Colonoscopy

Intervention Type PROCEDURE

Undergo Colonoscopy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Dietary Fiber

Given PO

Intervention Type DIETARY_SUPPLEMENT

Proctoscopy or anoscopy with Biopsy

Undergo proctoscopy or anoscopy

Intervention Type PROCEDURE

Colonoscopy

Undergo Colonoscopy

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Fiber

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No