IBD (Inflammatory Bowel Disease)NCT07247994
Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease
An observational study of IBD (Inflammatory Bowel Disease), run by Bishoy Shehata Fahim.
Trial summary
screen for neurologic and psychiatric disorders in children and adolescents with IBD. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Mar 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed with inflammatory bowel disease in Assiut university child hospital
Who may be able to join
- patients with IBD aged from from 1 to18 years old.
Who cannot join
- patients with IBD and aged above 18 years old or below 1 year old
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- Extraintestinal manifestations, Inflammatory bowel disease, Ibd
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the period from January 2026 to January 2027.
screen for neurologic and psychiatric disorders in children and adolescents with IBD.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Bishoy Shehata Fahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bishoy Shehata Fahim, Assiut University
- Investigators
- Nagla Hassan Abufaddan, Professor, Study director, Assiut university child hospitalRanda Kandeel Abdelaleem, Lecturer, Study director, Assiut university child hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247994
- Sponsor's protocol ID
- EIMs in Children with IBD
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Individual data sharing
- Undecided
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.
PubMed 39238799Kliegman, 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.
PubMed 24700662Zhao 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.
PubMed 33582812Mosli 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.
PubMed 34722642ulia 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.
PubMed 37351850Rogler 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.
PubMed 34358489
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease in Assiut University Child Hospital
- ClinicalTrials.gov ID
- NCT07247994
- Acronym / sponsor ID
- EIMs in Children with IBD
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- Extraintestinal manifestations, Inflammatory bowel disease, Ibd
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Bishoy Shehata FahimUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
screen for neurologic and psychiatric disorders in children and
adolescents with IBD.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with inflammatory bowel disease in Assiut university child hospital
Key inclusion criteria (1 listed)
- patients with IBD aged from from 1 to18 years old.
Key exclusion criteria (1 listed)
- patients with IBD and aged above 18 years old or below 1 year old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
screen for neurologic and psychiatric disorders in children and adolescents with IBD.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Results publication: PubMed 39238799Alsakarneh 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.
- Results publicationKliegman, 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.
- Results publication: PubMed 24700662Ben-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.
- Results publication: PubMed 33582812Zhao 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.
- Results publication: PubMed 34722642Mosli 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.
- Results publicationulia 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.
- Results publication: PubMed 37351850Gordon 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.
- Results publication: PubMed 34358489Rogler 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nagla Hassan Abufaddan, Professor study director
Assiut university child hospital
Randa Kandeel Abdelaleem, Lecturer study director
Assiut university child hospital
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease), run by Bishoy Shehata Fahim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bishoy Shehata Faheem, Resident doctor (+201551312246, bishoyshehata116@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07247994, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.