Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
Study NCT ID:
NCT06742606
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-19
First Post:
2024-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'patients diagnosed as IBD\n\nInclusion Criteria:\n\n1. Age: patients diagnosed as IBD aged from 1 month to 16 years\n2. Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings (Levine et al, 2014).\n3. Patients initially severely diseased or in relapse and planned to start or change biological therapy.\n\nExclusion Criteria:\n\n1. Patients already on biological therapy and controlled.\n2. Patients with known humeral or cell mediated immunodeficiency.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare efficacy of different biologicals in induction of remission by histopathological remission using histological DCA scoring system', 'timeFrame': '48 weeks', 'description': 'response to treatment Frequency of relapses, Control of symptoms and Following up growth pattern.\n\nhistopathological scoring assessment will be by using Inflammatory Bowel Disease-Distribution, Chronicity, Activity \\[IBD-DCA\\] Score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biological therapy , IBD'], 'conditions': ['Effect of Drug']}, 'descriptionModule': {'briefSummary': 'Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.', 'detailedDescription': "IBD are multifactorial disorders characterized by chronic relapsing intestinal inflammation (Fousekis et al .,2021). Main subtypes of pediatric IBD are Crohn's disease (CD), ulcerative colitis (UC), and IBD unclassified (Corica \\& Romano .., 2017) Mechanism of IBD involves uncontrolled immune mediated inflammatory response in genetically predisposed individuals to an unknown environmental trigger that interacts with gut microbiome and primarily affects gastrointestinal tract ( Iyer \\& Corr ..,2021) Pediatric onset IBD is more aggressive and rapidly progressive disease compared to adult onset IBD. Nearly a quarter of all patients with IBD develop this disease during childhood (Moon .., 2019), mean age at diagnosis ranged from 4.5 to 16 years in pediatric cases (Mosli et al ..,2021) Rates of pediatric onset IBD continue to rise around the world (Kuenzig et al ..,2022 ).\n\nIn2018, the highest annual incidences of pediatric IBD were 23/100000 person in Europe, 15.2/100000 in North America, and 11.4/100000 in Asia/ Middle East and Oceania (Sýkora et al .., 2018) Pediatric IBD management and therapeutic approach can be chall enging, especially in younger patients (Romeo et al .., 2020 )). Biologic agents have revolutionized the treatment paradigm of pediatric IBD (Kapoor \\& Crowley ..,2021) Biological drugs are monoclonal antibodies target specific cytokines involved in inflammatory cascade, such as tumour necrosis factor alpha (TNFα), integrins or interleukin 12/23, and have been approved for both pediatric CD and UC (Romeo et al 2020)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings.\n\nPatients initially severely diseased or in relapse and planned to start or change biological therapy.\n\nExclusion Criteria:\n\nPatients already on biological therapy and controlled. Patients with known humeral or cell mediated immunodeficiency.\n\nEthical'}, 'identificationModule': {'nctId': 'NCT06742606', 'briefTitle': 'Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'biological therapy and IBD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients diagnosed as IBD aged from 1 month to 16 years', 'description': 'study will include 2 groups of pediatric IBD patients planned to start biological treatment or change to other biological therapy and each group formed of 20 patients Group\n\n1 of patients will receive Adalimumab while Group 1 will receive ustekinumab', 'interventionNames': ['Biological: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab']}], 'interventions': [{'name': 'Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab', 'type': 'BIOLOGICAL', 'description': "All the patients will be treated according to guidelines of ECCO/ESPGHAN and will be followed up regularly for 12 months by assessment\n\n• response to treatment Frequency of relapses,\n\nRegular assessment will be:\n\nClinically every 2 to 4 weeks at gastroenterology outpatient clinic by using activity scoring systems:\n\npediatric Ulcerative Colitis Activity Index pediatric Chron's Disease Activity Index\n\nLaboratory follow up will done at weeks 12,24,36,48 of starting or changing to other biological by doing inflammatory markers( CBC, ESR, CRP, albumin. At the end of study(week 48) each patient will be reassessed by:\n\nDisease activity:\n\nLaboratory Endoscopy will be repeated at week 48 of starting or changing to other biological to assess effect of biologicals on reach mucosal healing.", 'armGroupLabels': ['patients diagnosed as IBD aged from 1 month to 16 years']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed nageh abdelhamed, master degree in pediatrics', 'role': 'CONTACT', 'phone': 'hossam26620@gmail.com', 'phoneExt': '2001150181507'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}