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Impact of Dietary Fiber Supplementation on Colonic Microbiome

Changes in Colonic Microbiome With Fiber Supplementation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 28 days
  • Procedures mentioned: Biopsies, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "OUTLINE: Patients receive dietary fiber orally (PO) once daily (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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether taking fiber each day changes the microbes (tiny living things) on the inner lining of the colon. It may help show whether fiber can prevent polyps, growths that can turn into cancer. The study is for adults with certain noncancerous anal or rectal problems or those having a routine colonoscopy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You can understand the study and are willing to sign a form agreeing to join.
  • You are seeking care mainly for a noncancerous anal or rectal problem, such as hemorrhoids (swollen veins), anal fissures (tears), or anal fistulas (abnormal tunnels), without an underlying illness such as colon or rectal cancer or Crohn’s disease. Or, you are having a colonoscopy as part of your usual care (a camera exam of the colon).

Who can't join

  • You currently have cancer.
  • You have Crohn’s disease or ulcerative colitis, illnesses that cause swelling and irritation in the gut.
  • You have a weakened immune system.
  • You have an inherited condition that raises colon cancer risk, such as Lynch syndrome or familial adenomatous polyposis (FAP).
  • You have had surgery to remove all or part of your colon.
  • The first study scope exam finds a colon or rectal problem, such as cancer or proctitis (swelling and irritation of the rectum).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

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