Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-04 @ 5:49 AM
Study NCT ID:
NCT02038504
Status:
COMPLETED
Last Update Posted:
2014-06-30
First Post:
2014-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Role of EN in NTIS Among Fistula Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016154', 'term': 'Digestive System Fistula'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-27', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thyroid function', 'timeFrame': 'Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled.', 'description': 'Thyroid function assessment includes level of free triiodothyronine,total triiodothyronine,free thyroxin,total thyroxin,thyroid stimulating hormone,thyroid stimulating hormone index,and standard thyroid stimulating hormone index'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastrointestinal fistula', 'enteral nutrition', 'thyroid function'], 'conditions': ['Gastrointestinal Fistula']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.', 'detailedDescription': 'Nonthyroidal illness syndrome (NTIS) is a common alterations in thyroid function observed in about 70% of hospitalized patients, with or without acute systemic illnesses. Mechanisms in the pathogenesis of NTIS are not yet well understood. Our previous study demonstrated that NTIS occurred frequently with a prevalence of 57.5% in gastrointestinal fistulas patients. In recent study, it has been shown that early enteral nutrition decreases the duration of hospitalization and mortality in the burn population, indicating a potential role of enteral nutrition in NTIS.In addition, the management of fistula patients requires bundle therapy including Nutrition therapy, especially enteral nutrition.The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Department of general surgery in Jinling hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of gastrointestinal fistula\n* Clinical diagnosis of nonthyroidal illness syndrome\n* Using enteral nutrition for fistula management\n\nExclusion Criteria:\n\n* patients who were prescribed drug which may affect thyroid function before or in our study\n* patients who were diagnosed as primary thyroid disease'}, 'identificationModule': {'nctId': 'NCT02038504', 'acronym': 'EN;NTIS', 'briefTitle': 'Investigating the Role of EN in NTIS Among Fistula Patients', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'a Prospective Study to Investigate the Role of Enteral Nutrition in Nonthyroidal Illness Syndrome Among Fistula Patients', 'orgStudyIdInfo': {'id': 'NTIS-EN-1'}, 'secondaryIdInfos': [{'id': '81270478', 'type': 'OTHER', 'domain': 'National Natural Science Foundation of China'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'gastrointestinal fistula'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of General Surgery, Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'VIce-president of General Surgery, Jinling Hospital, Professor of Medical School of Nanjing University', 'investigatorFullName': 'Jianan Ren', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}