Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT07247994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screening for Neurological manifestations among children diagnosed with inflammatory bowel disease in Assiut university children hospital', 'timeFrame': 'during the period from January 2026 to January 2027.', 'description': 'Neurologic symptoms have a great importance in early diagnosis and\n\ntreatment preventing major morbidity and later sequelae, especially if they\n\nprecede GI symptoms\n\nThe prevalence of neurologic manifestations of IBD varies between 0.2% and\n\n36%. Their pathogenesis of neurologic manifestations in IBD consists of 6\n\nmechanisms: 1.malabsorption and nutritional deficiency 2.metabolic agents\n\n3.infections complicating immune suppression 4.side effects of medications or\n\niatrogenic as a surgical complication 5.thromboembolism 6.immunological\n\nfactors\n\nUC patients are similar to or higher than CD patients in the probability of\n\nneurologic symptoms. Neurologic manifestations and complications include:\n\nheadache, dizziness, hypotonia, ADHD, tics, sensory complaints, seizures,\n\nneuropsychiatric disorders, peripherial neuropathy, meningitis, vestibular\n\ndysfunction, idiopathic IC hypertension, cerebral vasculitis, demyelinating\n\ndisorders and migraine'}, {'measure': 'screen for neurologic and psychiatric disorders in children and adolescents with IBD.', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Extraintestinal manifestations', 'Inflammatory bowel disease', 'Ibd'], 'conditions': ['IBD (Inflammatory Bowel Disease)']}, 'referencesModule': {'references': [{'pmid': '39238799', 'type': 'RESULT', 'citation': 'Alsakarneh S, Ahmed M, Jaber F, Abuassi M, Mourad FH, Francis FF, Barada K, Tfayli R, Al-Bawardy B, Farraye FA, Hashash JG. Inflammatory bowel disease burden in the Middle East and North Africa Region: a comprehensive analysis of incidence, prevalence, and mortality from 1990-2019. Ann Gastroenterol. 2024 Sep-Oct;37(5):527-535. doi: 10.20524/aog.2024.0909. Epub 2024 Aug 19.'}, {'type': 'RESULT', 'citation': 'Kliegman, Nathan J. Blum, Robert C. Tasker, Karen M. Wilson, Joseph W. St Geme, Abigail M. Schuh, Cara L. Mack, Matthew A. Deadorf, Nelson textbook of pediatrics edition 22, Elseveir, vol 2, 2024, pp 2309- 2325.'}, {'pmid': '24700662', 'type': 'RESULT', 'citation': 'Ben-Or O, Zelnik N, Shaoul R, Pacht A, Lerner A. The neurologic profile of children and adolescents with inflammatory bowel disease. J Child Neurol. 2015 Apr;30(5):551-7. doi: 10.1177/0883073814521296. Epub 2014 Apr 2.'}, {'pmid': '33582812', 'type': 'RESULT', 'citation': 'Zhao M, Gonczi L, Lakatos PL, Burisch J. The Burden of Inflammatory Bowel Disease in Europe in 2020. J Crohns Colitis. 2021 Sep 25;15(9):1573-1587. doi: 10.1093/ecco-jcc/jjab029.'}, {'pmid': '34722642', 'type': 'RESULT', 'citation': 'Mosli M, Alawadhi S, Hasan F, Abou Rached A, Sanai F, Danese S. Incidence, Prevalence, and Clinical Epidemiology of Inflammatory Bowel Disease in the Arab World: A Systematic Review and Meta-Analysis. Inflamm Intest Dis. 2021 Sep 7;6(3):123-131. doi: 10.1159/000518003. eCollection 2021 Sep.'}, {'type': 'RESULT', 'citation': 'ulia Gorospe, Joseph Windsor, Lindsay Hracs, Stephanie coward, Michael Buie, Joshua Quan, Lea Caplan, Trends in infammatory bowel disease incidence and prevalence across epidemiologic stages: a global systematic review with meta-analysis, the crohns and colitis foundation and AGA institute, 2024.'}, {'pmid': '37351850', 'type': 'RESULT', 'citation': 'Gordon H, Burisch J, Ellul P, Karmiris K, Katsanos K, Allocca M, Bamias G, Barreiro-de Acosta M, Braithwaite T, Greuter T, Harwood C, Juillerat P, Lobaton T, Muller-Ladner U, Noor N, Pellino G, Savarino E, Schramm C, Soriano A, Michael Stein J, Uzzan M, van Rheenen PF, Vavricka SR, Vecchi M, Zuily S, Kucharzik T. ECCO Guidelines on Extraintestinal Manifestations in Inflammatory Bowel Disease. J Crohns Colitis. 2024 Jan 27;18(1):1-37. doi: 10.1093/ecco-jcc/jjad108. No abstract available.'}, {'pmid': '34358489', 'type': 'RESULT', 'citation': 'Rogler G, Singh A, Kavanaugh A, Rubin DT. Extraintestinal Manifestations of Inflammatory Bowel Disease: Current Concepts, Treatment, and Implications for Disease Management. Gastroenterology. 2021 Oct;161(4):1118-1132. doi: 10.1053/j.gastro.2021.07.042. Epub 2021 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'screen for neurologic and psychiatric disorders in children and\n\nadolescents with IBD.', 'detailedDescription': 'Neurologic symptoms have a great importance in early diagnosis and\n\ntreatment preventing major morbidity and later sequelae, especially if they\n\nprecede GI symptoms\n\nThe prevalence of neurologic manifestations of IBD varies between 0.2% and\n\n36%. Their pathogenesis of neurologic manifestations in IBD consists of 6\n\nmechanisms: 1.malabsorption and nutritional deficiency 2.metabolic agents\n\n3.infections complicating immune suppression 4.side effects of medications or\n\niatrogenic as a surgical complication 5.thromboembolism 6.immunological\n\nfactors\n\nUC patients are similar to or higher than CD patients in the probability of\n\nneurologic symptoms. Neurologic manifestations and complications include:\n\nheadache, dizziness, hypotonia, ADHD, tics, sensory complaints, seizures,\n\nneuropsychiatric disorders, peripherial neuropathy, meningitis, vestibular\n\ndysfunction, idiopathic IC hypertension, cerebral vasculitis, demyelinating\n\ndisorders and migraine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children diagnosed with inflammatory bowel disease in Assiut university child hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with IBD aged from from 1 to18 years old.\n\nExclusion Criteria:\n\n* patients with IBD and aged above 18 years old or below 1 year old'}, 'identificationModule': {'nctId': 'NCT07247994', 'briefTitle': 'Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease in Assiut University Child Hospital', 'orgStudyIdInfo': {'id': 'EIMs in Children with IBD'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bishoy Shehata Faheem, Resident doctor', 'role': 'CONTACT', 'email': 'bishoyshehata116@gmail.com', 'phone': '+201551312246'}], 'overallOfficials': [{'name': 'Nagla Hassan Abufaddan, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut university child hospital'}, {'name': 'Randa Kandeel Abdelaleem, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut university child hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bishoy Shehata Fahim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Bishoy Shehata Fahim', 'investigatorAffiliation': 'Assiut University'}}}}