Dietary Fiber for Colorectal Cancer

Overseen By Amber O'Connor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Active malignancy, Crohn's, Ulcerative colitis, Immunosuppressed, Hereditary colon cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vassiliki L Tsikitis, M.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for adults over 18 who've had a colonoscopy in the last 2 years and have benign anorectal issues like hemorrhoids, without cancer or Crohn's disease. They must understand and sign consent. It's not for those with hereditary colon cancer syndromes, past colon surgery, active malignancy, inflammatory bowel diseases or immunosuppression.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I have issues like hemorrhoids or anal fissures but no cancer or Crohn's disease.

Exclusion Criteria

I have a genetic condition related to colon cancer.

I have had polyps or cancer in my colon or rectum.

I have had part or all of my colon surgically removed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary fiber orally once daily for 28 days

4 weeks

1 visit (in-person) for proctoscopy or anoscopy, blood sample collection

Follow-up

Participants are monitored for changes in microbiome diversity and abundance after fiber supplementation

up to 12 days

1 visit (in-person) for follow-up proctoscopy or anoscopy, blood sample collection

Treatment Details

Interventions

• Dietary Fiber
• Proctoscopy or Anoscopy with Biopsy

Trial Overview The study investigates if taking daily dietary fiber supplements can alter the microorganisms in the gut lining to prevent precancerous polyps linked to colorectal cancer. Participants will undergo procedures like colonoscopy and answer questionnaires about their health.

Participant Groups

Group I: Supportive care (oral fiber) Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+