Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT05643859
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Dietary Fiber Supplementation on Colonic Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D011351', 'term': 'Proctoscopy'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}, {'measure': 'Change in microbiome colonic mucosa: microbiome diversity', 'timeFrame': 'Baseline and post-supplementation, up to 40 days', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Colorectal Neoplasm', 'Non-Neoplastic Anal Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To identify how diet, specifically fiber supplementation, alters the microbiome of the colonic mucosa.\n\nOUTLINE:\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>= 18 years\n* Ability to understand and the willingness to sign a written informed consent document\n* 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\n\nExclusion Criteria:\n\n* Patients with an active malignancy, Crohn's disease, ulcerative colitis, and immunosuppressed patients\n* Patients with hereditary colon cancer syndrome including Lynch syndrome or Familial Adenomatous Polyposis (FAP)\n* Patients with a prior history of total or partial colon resection\n* Colorectal pathology, such cancer or proctitis, after initial study scope"}, 'identificationModule': {'nctId': 'NCT05643859', 'briefTitle': 'Impact of Dietary Fiber Supplementation on Colonic Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Changes in Colonic Microbiome With Fiber Supplementation', 'orgStudyIdInfo': {'id': 'STUDY00024054'}, 'secondaryIdInfos': [{'id': 'NCI-2022-07495', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00024054', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Dietary Fiber', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fiber'], 'description': 'Given PO', 'armGroupLabels': ['Supportive care (oral fiber)']}, {'name': 'Proctoscopy or anoscopy with Biopsy', 'type': 'PROCEDURE', 'description': 'Undergo proctoscopy or anoscopy', 'armGroupLabels': ['Supportive care (oral fiber)']}, {'name': 'Colonoscopy', 'type': 'PROCEDURE', 'description': 'Undergo Colonoscopy', 'armGroupLabels': ['Supportive care (oral fiber)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (oral fiber)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vassiliki L. Tsikitis, M.D.', 'role': 'CONTACT', 'email': 'tsikitis@ohsu.edu', 'phone': '503-494-1735'}, {'name': 'Vassiliki L. Tsikitis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Shahrose Rahman, M.D.', 'role': 'CONTACT', 'email': 'rahmasha@ohsu.edu', 'phone': '503-494-8652'}, {'name': "Amber O'Connor", 'role': 'CONTACT', 'email': 'oconnoam@ohsu.edu'}], 'overallOfficials': [{'name': 'Vassiliki L Tsikitis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Study team plans to publish the results in the Journal for Microbiome'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vassiliki Tsikitis', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}