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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 below
Select...
I am 18 years old or older.

Timeline

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

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

Dietary Fiber (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05643859 — N/A
Colorectal Neoplasms Research Study Groups: Supportive care (oral fiber)
Colorectal Neoplasms Clinical Trial 2023: Dietary Fiber Highlights & Side Effects. Trial Name: NCT05643859 — N/A
Dietary Fiber (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643859 — N/A

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."

Answered by AI
~54 spots leftby Dec 2024