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Dietary Supplement
Supportive care (oral fiber) for Colorectal Neoplasms
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
Age >= 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-supplementation, up to 40 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in microbiome colonic mucosa: microbiome diversity
Change in microbiome colonic mucosa: taxa abundance
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
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
226 Previous Clinical Trials
2,090,383 Total Patients Enrolled
6 Trials studying Colorectal Neoplasms
19,907 Patients Enrolled for Colorectal Neoplasms
Vassiliki L Tsikitis, M.D.Principal InvestigatorOHSU Knight Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic condition related to colon cancer.I am 18 years old or older.I have had polyps or cancer in my colon or rectum.I have issues like hemorrhoids or anal fissures but no cancer or Crohn's disease.I have had part or all of my colon surgically removed.I have an active cancer, Crohn's disease, ulcerative colitis, or am immunosuppressed.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (oral fiber)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for individuals to partake in this trial?
"As confirmed by clinicaltrials.gov, this particular medical study is not open for recruitment at the moment. The trial first went live on December 1st 2022 and had its last update on that same date. However, there are 865 other studies actively searching for potential test subjects right now."
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