Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT06353633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D000092724', 'term': 'Elimination Diets'}], 'ancestors': [{'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCDAI', 'timeFrame': '8 weeks', 'description': 'pediatric chron disease activity index'}, {'measure': 'CRP', 'timeFrame': '8 weeks', 'description': 'c-reactive protein'}, {'measure': 'ESR', 'timeFrame': '8 weeks', 'description': 'erythrocyte sedimentation rate'}, {'measure': 'FC', 'timeFrame': '8 weeks', 'description': 'fecal calprotectin'}, {'measure': 'Alb', 'timeFrame': '8 weeks', 'description': 'serum albumin'}], 'secondaryOutcomes': [{'measure': 'Arm Circumferance', 'timeFrame': '8 weeks', 'description': 'the circumference of the arm'}, {'measure': 'BMI', 'timeFrame': '8 weeks', 'description': 'body mass index'}, {'measure': 'Height', 'timeFrame': '8 weeks', 'description': 'height measurement'}, {'measure': 'weight', 'timeFrame': '8 weeks', 'description': 'body weight'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PEN'], 'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': "In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children aged 4 to 18 years with active Crohn's disease\n* Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40\n\nExclusion Criteria:\n\n* Patients who receiving concurrent remission-inducing drugs such as steroids, 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic"}, 'identificationModule': {'nctId': 'NCT06353633', 'briefTitle': "The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': "The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease", 'orgStudyIdInfo': {'id': 'AHekmatdoost'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'exclusion diet along with formula', 'interventionNames': ['Dietary Supplement: formula', 'Behavioral: exclusion diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A group that receives only exclusion diet', 'interventionNames': ['Behavioral: exclusion diet']}], 'interventions': [{'name': 'formula', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The calories needed by the person are calculated and half of the calories are provided by formulas and the other half based on the elimination diet', 'armGroupLabels': ['exclusion diet along with formula']}, {'name': 'exclusion diet', 'type': 'BEHAVIORAL', 'description': 'In this group, only the elimination diet is considered as an intervention', 'armGroupLabels': ['A group that receives only exclusion diet', 'exclusion diet along with formula']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Azita Hekmatdoost, MD, PhD', 'role': 'CONTACT', 'email': 'a_hekmat2000@yahoo.com', 'phone': '09123065084'}], 'overallOfficials': [{'name': 'Azita Hekmatdoost, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NNFTRI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}