NCT07247994

Brief Summary

screen for neurologic and psychiatric disorders in children and adolescents with IBD.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jan 2026Mar 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Extraintestinal manifestationsInflammatory bowel diseaseIbd

Outcome Measures

Primary Outcomes (2)

  • Screening for Neurological manifestations among children diagnosed with inflammatory bowel disease in Assiut university children hospital

    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.

    1 year

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children diagnosed with inflammatory bowel disease in Assiut university child hospital

You may qualify if:

  • patients with IBD aged from from 1 to18 years old.

You may not qualify if:

  • patients with IBD and aged above 18 years old or below 1 year old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIrritable Bowel Syndrome

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases, FunctionalColonic Diseases

Study Officials

  • Nagla Hassan Abufaddan, Professor

    Assiut university child hospital

    STUDY DIRECTOR
  • Randa Kandeel Abdelaleem, Lecturer

    Assiut university child hospital

    STUDY DIRECTOR

Central Study Contacts

Bishoy Shehata Faheem, Resident doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

November 25, 2025

Record last verified: 2025-11