Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-05 @ 5:17 PM
Study NCT ID:
NCT03385850
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2017-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-02', 'studyFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2017-12-27', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-d mortality', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'immune parameters', 'timeFrame': '7 days', 'description': 'serum Th17 and Treg lymphocyte percentages'}, {'measure': 'immune parameters', 'timeFrame': '7 days', 'description': 'IL-23, IL-17, IL-6, IL-10 levels'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Immune System Disorder', 'Enteral Feeding']}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate the roles of Th17/Treg cells and IL-23/IL-17 axis in the mechanisms of early enteral nutrition (EEN) correcting immune imbalance of sepsis by means of improving the intestinal flora disturbance. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of sepsis\n2. Within 3 days of sepsis onset before ICU admission\n3. No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission\n\nExclusion Criteria:\n\n1. Ileus\n2. Digestive tract hemorrhage\n3. Inflammatory bowel disease\n4. Abdominal hypertension (IAP \\>25mmHg)\n5. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)\n6. Malnutrition or immunodeficiency\n7. Long-term use of hormones'}, 'identificationModule': {'nctId': 'NCT03385850', 'briefTitle': 'The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'The Roles of Th17/Treg Cells and IL-23/IL-17 Axis in the Mechanisms of Early Enteral Nutrition Improving Immune Function of Sepsis', 'orgStudyIdInfo': {'id': 'NanjingFirst'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'early enteral nutrition', 'interventionNames': ['Other: enteral nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'delayed enteral nutrition', 'interventionNames': ['Other: enteral nutrition']}], 'interventions': [{'name': 'enteral nutrition', 'type': 'OTHER', 'description': 'early enteral nutrition group or delayed enteral nutrition group', 'armGroupLabels': ['delayed enteral nutrition', 'early enteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Xiang Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There is a plan to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'XiangWang', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}