Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-03-26 @ 9:30 PM
Study NCT ID:
NCT06102668
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival and PN Dependence in SBS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-21', 'studyFirstSubmitDate': '2023-10-21', 'studyFirstSubmitQcDate': '2023-10-21', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '2012/1/1-2019/1/1', 'description': 'Survival rate in patients with SBS'}, {'measure': 'Parenteral nutrition dependence', 'timeFrame': '2012/1/1-2019/1/1', 'description': 'Parenteral nutrition dependence in patients with SBS'}], 'secondaryOutcomes': [{'measure': 'Risk factors', 'timeFrame': '2012/1/1-2019/1/1', 'description': 'Risk factors of mortality and parenteral dependence in patients with SBS'}, {'measure': 'Cause of death', 'timeFrame': '2012/1/1-2019/1/1', 'description': 'Cause of death in patients with SBS at the end of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Short Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The objective of this study was to determine the longterm survival and parenteral nutrition dependence of adult patients with SBS.', 'detailedDescription': 'Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. Patients with SBS often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. SBS can cause various metabolic and physiologic disturbances. Although parenteral nutrition is a life-saving measure for many patients with SBS, patients with SBS is associated with decreased survival and parenteral nutrition (PN) dependence. Few studies have reported the survival and PN dependence in adult SBS patients in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with SBS caused by extensive bowel resection with a remnant small intestine length of \\<200cm.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients diagnosed with SBS.\n\nExclusion Criteria:\n\n* age \\<18 years; patients with active malignant tumors.'}, 'identificationModule': {'nctId': 'NCT06102668', 'briefTitle': 'Survival and PN Dependence in SBS Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of University of Science and Technology of China'}, 'officialTitle': 'Long-term Survival and Parenteral Nutrition Dependence in Adult Patients With Non-malignant Short Bowel Syndrome', 'orgStudyIdInfo': {'id': 'FirstAHUSTChina'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'JIANFENG GONG, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinling Hospital, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of University of Science and Technology of China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinling Hospital, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}