Clinical trial · Interventional
Impact of Dietary Fiber Supplementation on Colonic Microbiome
Changes in Colonic Microbiome With Fiber Supplementation
NCT05643859CI-TRIAL-00100958recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Colorectal Neoplasm | Benign Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Non-Neoplastic Anal Disorder | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
| Dietary Fiber | Dietary Supplement | — | UNRESOLVED |
| Proctoscopy or anoscopy with Biopsy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (oral fiber)
- description
- 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.
- interventionNames
- Dietary Supplement: Dietary Fiber
- Procedure: Proctoscopy or anoscopy with Biopsy
- Procedure: Colonoscopy
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Change in microbiome colonic mucosa: taxa abundance
- timeFrame
- Baseline and post-supplementation, up to 40 days
- description
- Will use data visualization techniques to understand the data and determine if microbiome count overall (richness) changes occur in patients who are started on fiber supplementation. In order to visualize overall changes after fiber supplementation, will generate plots showing relative abundance of the detected taxa for each subject at baseline and post-supplementation. For each taxa, will generate box plots to visually compare the median and interquartile range (IQR) of abundance between the two time points. Wilcoxon signed rank tests with an alpha level of 0.05 will determine if there is a difference in microbial derived short chain fatty acids after fiber supplementation in the blood and mucosa. Wilcoxon signed rank tests with an alpha level of 0.05 will determine if there is a difference in microbial derived short chain fatty acids after fiber supplementation in the blood and mucosa.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.