Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:36 PM
Study NCT ID:
NCT07424469
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foregut Leaks-Role of Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial composition of samples', 'timeFrame': 'During the surgery', 'description': 'change in virulence factors, microbial response to treatment modalities'}, {'measure': 'Time of healing of leaks', 'timeFrame': 'From index intervention until documented leak resolution ( up to 24 weeks)', 'description': 'Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation.'}, {'measure': 'Proportion of patients achieving leak closure without need for additional surgical intervention', 'timeFrame': 'Up to 24 weeks post-surgery', 'description': 'Successful endoscopic management will be defined as complete leak resolution without requirement for subsequent operative surgical repair. This will be measured as a percentage of participants.'}, {'measure': 'Incidence of postoperative complications', 'timeFrame': 'Within 30 days post-surgery', 'description': 'Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Patient demographics', 'timeFrame': 'Baseline or anytime before surgery', 'description': 'age, sex, race, ethnicity'}, {'measure': 'Patient risk of postoperative complications', 'timeFrame': 'Post surgery until the time leak is healed ( up to 24 weeks)', 'description': 'Calculated by ACS risk calculator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Diseases']}, 'descriptionModule': {'briefSummary': 'Aims\n\n1. To understand the microbial composition involved with foregut leaks\n2. To define the virulence changes in the microbiota following foregut leaks\n3. To identify host response mechanisms and how they change with interventions\n4. Utilize this information to improve patient outcomes', 'detailedDescription': 'For this study, investigators will compare the microbial composition of the infected fluid from the leak to that of a tissue sample taken from the participant. This will allow investigators to compare the composition and virulence of the microbiome both within and between participants. These comparisons will help further the understanding of the pathogenesis of these leaks, as well as identify which participants may be most at risk of developing postoperative leaks. The combination of this information has the potential to contribute to the development of preventative measures and improve patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an esophageal or stomach leak\n* Over 18 years old\n\nExclusion Criteria:\n\n* Patients determined by physician/surgeon as not able to tolerate biopsy\n* Under 18 years old'}, 'identificationModule': {'nctId': 'NCT07424469', 'briefTitle': 'Foregut Leaks-Role of Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'The Role the Microbiome Plays in Foregut Leaks: Understanding and Utilizing This Information to Improve Patient Outcomes', 'orgStudyIdInfo': {'id': '020-307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sample collection', 'description': 'Samples of microbial fluid and host biopsy taken', 'interventionNames': ['Other: Biopsy and fluid samples']}], 'interventions': [{'name': 'Biopsy and fluid samples', 'type': 'OTHER', 'description': 'Biopsy and fluid samples taken during other medically necessary procedure', 'armGroupLabels': ['Sample collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rehma Shabbir', 'role': 'CONTACT', 'email': 'Rehma.Shabbir@BSWHealth.org', 'phone': '214-820-1722'}], 'facility': 'Baylor Scott & White Center for Advanced Surgery', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Rehma Shabbir', 'role': 'CONTACT', 'email': 'Rehma.Shabbir@BSWHealth.org', 'phone': '2148201722'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}