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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-07495 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00024054 | Other Identifier | OHSU Knight Cancer Institute |
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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.
PRIMARY OBJECTIVE:
I. To identify how diet, specifically fiber supplementation, alters the microbiome of the colonic mucosa.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (oral fiber) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Fiber | Dietary Supplement | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiome colonic mucosa: taxa abundance | 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. | Baseline and post-supplementation, up to 40 days |
| Change in microbiome colonic mucosa: microbiome diversity | Will use data visualization techniques to understand the data and determine if the types of metabolites (microbiome diversity) cases occur in patients who are started on fiber supplementation. In order to visualize overall changes after fiber supplementation. To assess for changes in microbiome diversity, our primary analysis will compare median Shannon diversity index values at baseline and post-supplementation. The Shannon index estimates diversity using richness and abundance. Will calculate Shannon index values for each participant at each time point and use a Wilcoxon signed rank test with an alpha level of 0.05 to determine if there is a difference in microbiome diversity after fiber supplementation. | Baseline and post-supplementation, up to 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahrose Rahman, M.D. | Contact | 503-494-8652 | rahmasha@ohsu.edu | |
| Amber O'Connor | Contact | oconnoam@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vassiliki L Tsikitis, M.D. | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
Study team plans to publish the results in the Journal for Microbiome
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D011351 | Proctoscopy |
| D001706 | Biopsy |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Proctoscopy or anoscopy with Biopsy | Procedure | Undergo proctoscopy or anoscopy |
|
| Colonoscopy | Procedure | Undergo Colonoscopy |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |