Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 1:34 PM
Study NCT ID:
NCT06648551
Status:
RECRUITING
Last Update Posted:
2024-10-18
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Performance of Controlling Nutritional Status as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C565234', 'term': 'Inflammatory Bowel Disease 5'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-10-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic test', 'timeFrame': 'one year', 'description': 'sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease 5']}, 'descriptionModule': {'briefSummary': 'The objective of this observational study is to determine the diagnostic performance of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease. The main questions to be answered are:\n\nWhat is the sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease?\n\nThe participants will:\n\nUndergo body composition analysis and a medical history review to understand the characteristics of their current condition, apply the GLIM criteria, and conduct their nutritional assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Ulcerative Colitis patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Gender unspecified\n* Histologically confirmed Ulcerative Colitis\n* Diagnosis confirmed by a specialist physician\n\nExclusion Criteria:\n\n* Patients with any amputation or prosthesis\n* Patients with a pacemaker\n* Patients with any neoplasm\n* Pregnancy or lactation\n* With comorbidities such as diabetes, hypertension, heart failure, thyroid problems'}, 'identificationModule': {'nctId': 'NCT06648551', 'acronym': 'CONUT', 'briefTitle': 'Diagnostic Performance of Controlling Nutritional Status as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital General de Mexico'}, 'officialTitle': 'Diagnostic Performance of CONUT as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'DI/23/501/03/31'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CONUT', 'type': 'DIAGNOSTIC_TEST', 'description': 'It is a scale that uses albumin, lymphocytes, and cholesterol for the diagnosis of malnutrition'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06720', 'city': 'Mexico City', 'state': 'Cuauhtemoc', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Nalllely Bueno Hernandez, PhD', 'role': 'CONTACT', 'email': 'nallely_bh5@yahoo.com.mx', 'phone': '27892000', 'phoneExt': '5654'}, {'name': 'Viridiana M Mendoza Martinez, B.S.', 'role': 'CONTACT', 'email': 'dinvestigacionhgm@gmail.com', 'phone': '5529370762'}], 'facility': 'Nallely Hernandez Bueno', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General de Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Sciences Researcher C', 'investigatorFullName': 'Nallely Bueno Hernández', 'investigatorAffiliation': 'Hospital General de Mexico'}}}}