Effects of fiber supplements on gut bacteria in the colon
Official title: Changes in Colonic Microbiome With Fiber Supplementation
Run by OHSU Knight Cancer Institute · NCT05643859 · Data updated 2026-11-12
This study is testing if taking daily fiber supplements can change the gut bacteria in the colon to help prevent precancerous polyps.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | April 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT05643859 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with benign anorectal conditions who are undergoing standard colonoscopy procedures.
✕Probably not a fit
Patients with active malignancies, inflammatory bowel diseases, or hereditary colon cancer syndromes will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates how daily fiber supplementation influences the microbiome of the colonic mucosa over a 28-day period. Participants will take dietary fiber orally and may undergo standard procedures like proctoscopy or colonoscopy for assessment. The primary goal is to determine the impact of dietary fiber on the gut microbiome, which is crucial for preventing the development of precancerous polyps. Blood samples will also be collected for further analysis.
Why it matters
Potential benefit: If successful, this study could help in preventing the formation of precancerous polyps in patients at risk.
How similar studies have gone: Other studies have shown promising results in modifying the gut microbiome through dietary interventions, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
OHSU Knight Cancer Institute
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Vassiliki L Tsikitis, M.D. — OHSU Knight Cancer Institute
- Study coordinator: Shahrose Rahman, M.D.
- Email: rahmasha@ohsu.edu
- Phone: 503-494-8652
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.