Dietary Fiber for Colorectal Cancer

N/A

Recruiting

Led By Vassiliki L Tsikitis, M.D.

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post-supplementation, up to 40 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if fiber supplements can change gut microbes to help reduce colon cancer risk.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this trial focuses on dietary fiber supplementation which typically has minimal side effects such as bloating or gas, procedures like colonoscopies may cause discomfort, bleeding, or rarely perforation of the colon wall.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post-supplementation, up to 40 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post-supplementation, up to 40 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-supplementation, up to 40 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in microbiome colonic mucosa: microbiome diversity

Change in microbiome colonic mucosa: taxa abundance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (oral fiber)Experimental Treatment4 Interventions

Patients receive dietary fiber PO 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colonoscopy

2012

Completed Phase 3

~115560

Dietary Fiber

2016

N/A

~210