- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07247994
Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease
Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease in Assiut University Child Hospital
screen for neurologic and psychiatric disorders in children and
adolescents with IBD.
Study Overview
Status
Conditions
Detailed Description
Neurologic symptoms have a great importance in early diagnosis and
treatment preventing major morbidity and later sequelae, especially if they
precede GI symptoms
The prevalence of neurologic manifestations of IBD varies between 0.2% and
36%. Their pathogenesis of neurologic manifestations in IBD consists of 6
mechanisms: 1.malabsorption and nutritional deficiency 2.metabolic agents
3.infections complicating immune suppression 4.side effects of medications or
iatrogenic as a surgical complication 5.thromboembolism 6.immunological
factors
UC patients are similar to or higher than CD patients in the probability of
neurologic symptoms. Neurologic manifestations and complications include:
headache, dizziness, hypotonia, ADHD, tics, sensory complaints, seizures,
neuropsychiatric disorders, peripherial neuropathy, meningitis, vestibular
dysfunction, idiopathic IC hypertension, cerebral vasculitis, demyelinating
disorders and migraine
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Bishoy Shehata Faheem, Resident doctor
- Phone Number: +201551312246
- Email: bishoyshehata116@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with IBD aged from from 1 to18 years old.
Exclusion Criteria:
- patients with IBD and aged above 18 years old or below 1 year old
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Screening for Neurological manifestations among children diagnosed with inflammatory bowel disease in Assiut university children hospital
Time Frame: during the period from January 2026 to January 2027.
|
Neurologic symptoms have a great importance in early diagnosis and treatment preventing major morbidity and later sequelae, especially if they precede GI symptoms The prevalence of neurologic manifestations of IBD varies between 0.2% and 36%. Their pathogenesis of neurologic manifestations in IBD consists of 6 mechanisms: 1.malabsorption and nutritional deficiency 2.metabolic agents 3.infections complicating immune suppression 4.side effects of medications or iatrogenic as a surgical complication 5.thromboembolism 6.immunological factors UC patients are similar to or higher than CD patients in the probability of neurologic symptoms. Neurologic manifestations and complications include: headache, dizziness, hypotonia, ADHD, tics, sensory complaints, seizures, neuropsychiatric disorders, peripherial neuropathy, meningitis, vestibular dysfunction, idiopathic IC hypertension, cerebral vasculitis, demyelinating disorders and migraine |
during the period from January 2026 to January 2027.
|
|
screen for neurologic and psychiatric disorders in children and adolescents with IBD.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nagla Hassan Abufaddan, Professor, Assiut university child hospital
- Study Director: Randa Kandeel Abdelaleem, Lecturer, Assiut university child hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIMs in Children with IBD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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