NCT05643859 Impact of Dietary Fiber Supplementation on Colonic Microbiome
| NCT ID | NCT05643859 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Benign Colorectal Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Vassiliki L Tsikitis, M.D.
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT05643859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Benign Colorectal Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05643859 currently recruiting?
Yes, NCT05643859 is actively recruiting participants. Contact the research team at rahmasha@ohsu.edu for enrollment information.
Where is the NCT05643859 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05643859 clinical trial?
NCT05643859 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Vassiliki L Tsikitis, M.D. at OHSU Knight Cancer Institute. The trial plans to enroll 120 participants.