Impact of Dietary Fiber Supplementation on Colonic Microbiome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary Fiber, Proctoscopy or anoscopy with Biopsy, Colonoscopy, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Benign Colorectal Neoplasm, Non-Neoplastic Anal Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Changes in Colonic Microbiome With Fiber Supplementation
Overview
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.
Interventions
- Dietary supplement Dietary Fiber
Given PO - Procedure Proctoscopy or anoscopy with Biopsy
Undergo proctoscopy or anoscopy - Procedure Colonoscopy
Undergo Colonoscopy - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Change in microbiome colonic mucosa: taxa abundance [Time frame: Baseline and post-supplementation, up to 40 days]
- Change in microbiome colonic mucosa: microbiome diversity [Time frame: Baseline and post-supplementation, up to 40 days]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- OHSU Knight Cancer Institute — Portland
Identifiers
NCT: NCT05643859 · STUDY00024054 · NCI-2022-07495 · STUDY00024054