Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-27 @ 7:13 PM
Study NCT ID:
NCT06066866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to isolate live bacteria from 95% of samples', 'timeFrame': '1-4 years', 'description': 'We aim to isolate live bacteria from 95% of samples'}], 'secondaryOutcomes': [{'measure': 'Ability to measure quantitative Colony Forming Units (CFUs) in 90% of samples', 'timeFrame': '1-4 years', 'description': 'We aim to measure quantitative Colony Forming Units (CFUs) in 90% of samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'IBS - Irritable Bowel Syndrome', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'GI disorders are influenced by the gut microbiome. To date, sampling of the small intestine in GI disorders has been limited. The investigators plan to sample the small intestinal contents during endoscopy for research purposes.', 'detailedDescription': 'Current guidelines (AGA Clinical Practice Update, 2020) report the definition of SIBO as a clinical entity lacks precision and consistency; it is a term generally applied to a clinical disorder where symptoms, clinical signs, and/or laboratory abnormalities are attributed to changes in the numbers of bacteria or in the composition of the bacterial population in the small intestine. To date, there is unlimited knowledge regarding the diagnostic criterion which has been limited by nonspecific and nonsensitive testing such as breath tests. Breath tests have a limited use in patients with IBS-D who inherently have increased gut transit time rendering the testing invalid for accurately measuring small intestinal bacteria. Additionally, the relationship between SIBO and symptoms in patients without obvious risk factors (such as anatomical changes due to surgery) is unknown. The investigators study aims to investigate the microbial landscape of the small intestine in healthy patients and those with GI disease (suspected or diagnosed) undergoing an upper endoscopy by collecting an aspirate of patient small intestinal fluid and studying it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18years\n* Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care\n\nExclusion Criteria:\n\nChildren (under age 18years) Pregnant Women and Fetuses Neonates (0 - 28 days) Impaired Decision Making Capacity'}, 'identificationModule': {'nctId': 'NCT06066866', 'briefTitle': 'Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment', 'orgStudyIdInfo': {'id': '71429'}}, 'armsInterventionsModule': {'interventions': [{'name': 'endoscopic sampling of luminal fluid', 'type': 'OTHER', 'description': 'We will collect luminal fluid via endoscopic sampling'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sean P Spencer, MD,PhD', 'role': 'CONTACT', 'email': 'seanspen@stanford.edu', 'phone': '(650) 736-5555'}], 'overallOfficials': [{'name': 'Sean P Spencer, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Linda A Nguyen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor, Stanford Gastroenterology and Hepatology', 'investigatorFullName': 'Sean Spencer', 'investigatorAffiliation': 'Stanford University'}}}}