Impact of Dietary Fiber Supplementation on Colonic Microbiome
Recruiting · NCT05643859 · Interventional (participants receive a specific treatment) · Lead sponsor: OHSU Knight Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
ColonoscopyDietary FiberProctoscopy or anoscopy with BiopsyQuestionnaire Administration
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- OHSU Knight Cancer Institute - Portland, Oregon, United States