Inflammatory Bowel DiseasesNCT07818473
Conventional vs Biologic Therapy in Pediatric IBD
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Assiut University.
Trial summary
This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 10 Jan 2028
- How long will I take part?
- 12 Months
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents up to 18 years of age with confirmed inflammatory bowel disease receiving conventional and/or biologic therapy at Assiut University Children Hospital and the Health Insurance IBD Committee, Assiut Branch.
Who may be able to join
- - Confirmed diagnosis of Crohn's disease, ulcerative colitis, or IBD-unclassified according to revised Porto criteria
- Age at diagnosis less than 18 years
- Receipt of conventional therapy and/or biologic therapy for a minimum evaluable treatment duration
- Availability of adequate medical records
- Written informed consent (for prospective component)
Who cannot join
- - Incomplete medical records precluding assessment of primary endpoints
- Age more than 18 years
- Discontinuation of follow-up before a minimum evaluable treatment period
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: Effectiveness, Safety, and Adverse Events of Conventional and Biologic Therapy in Pediatric Inflammatory Bowel Disease
This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut University Children Hospital.
Read the detailed description
Pediatric-onset inflammatory bowel disease differs from adult-onset disease in phenotype, disease extent, and long-term prognosis. Conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators) and biologic therapy (mainly anti-TNFα agents) are used for induction and maintenance of remission.
This observational cohort study will include pediatric patients with confirmed Crohn's disease, ulcerative colitis, or IBD-unclassified. Patients will be classified into conventional therapy and biologic therapy groups. Clinical remission, response rates, steroid-free remission, adverse events, and growth parameters will be assessed over a 12-month period.
- Keywords
- Pediatric IBD, Biologic therapy, Conventional therapy, Infliximab, Adalimumab, PCDAI, PUCAI, Assiut
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Patients managed with 5-aminosalicylates, corticosteroids, and/or immunomodulators without biologic exposure during the observation period. | |
| Biologic Therapy | Patients who received biologic therapy (with or without concomitant conventional agents) during the observation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate
Proportion of patients achieving clinical remission at week 8-12, 6 months, and 12 months, defined as PCDAI ≤ 10 for Crohn's disease or PUCAI < 10 for ulcerative colitis.
Measured: At week 8-12, 6 months, and 12 months
Secondary outcomes (5)
Clinical response rate
Proportion of patients achieving clinical response, defined as a decrease from baseline of ≥12.5 points in PCDAI (Crohn's disease) or ≥20 points in PUCAI (ulcerative colitis).
Measured: At week 8-12, 6 months, and 12 months
Steroid-free remission rate
Proportion of patients in clinical remission without systemic corticosteroid use.
Measured: At 12 months
Incidence of adverse events
Proportion of patients experiencing adverse events (infusion/injection reactions, infections, hematologic abnormalities, hepatotoxicity), graded according to CTCAE-adapted criteria
Measured: Through 12 months
Change in growth parameters
Change in height z-score, weight z-score, and BMI z-score from baseline.
Measured: From baseline to 12 months
Treatment escalation or switch rate
Proportion of patients requiring treatment escalation or switching between conventional and biologic agents.
Measured: Through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion10 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Makar Ishak, Assiut University
- Investigators
- Nafisa H Abdel-Aziz, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818473
- Sponsor's protocol ID
- IBD-Pediatric-Therapy-Assiut-2
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuenzig ME, Fung SG, Marderfeld L, Mak JWY, Kaplan GG, Ng SC, Wilson DC, Cameron F, Henderson P, Kotze PG, Bhatti J, Fang V, Gerber S, Guay E, Kotteduwa Jayawarden S, Kadota L, Maldonado D F, Osei JA, Sandarage R, Stanton A, Wan M; InsightScope Pediatric IBD Epidemiology Group; Benchimol EI. Twenty-first Century Trends in the Global Epidemiology of Pediatric-Onset Inflammatory Bowel Disease: Systematic Review. Gastroenterology. 2022 Apr;162(4):1147-1159.e4. doi: 10.1053/j.gastro.2021.12.282. Epub 2022 Jan 5.
PubMed 34995526Sykora J, Pomahacova R, Kreslova M, Cvalinova D, Stych P, Schwarz J. Current global trends in the incidence of pediatric-onset inflammatory bowel disease. World J Gastroenterol. 2018 Jul 7;24(25):2741-2763. doi: 10.3748/wjg.v24.i25.2741.
PubMed 29991879Sauer CG, Kugathasan S. Pediatric inflammatory bowel disease: highlighting pediatric differences in IBD. Gastroenterol Clin North Am. 2009 Dec;38(4):611-28. doi: 10.1016/j.gtc.2009.07.010.
PubMed 19913205Van Limbergen J, Russell RK, Drummond HE, Aldhous MC, Round NK, Nimmo ER, Smith L, Gillett PM, McGrogan P, Weaver LT, Bisset WM, Mahdi G, Arnott ID, Satsangi J, Wilson DC. Definition of phenotypic characteristics of childhood-onset inflammatory bowel disease. Gastroenterology. 2008 Oct;135(4):1114-22. doi: 10.1053/j.gastro.2008.06.081. Epub 2008 Jul 3.
PubMed 18725221
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety, and Adverse Events of Conventional and Biologic Therapy in Pediatric Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07818473
- Acronym / sponsor ID
- IBD-Pediatric-Therapy-Assiut-2
- Keywords
- Pediatric IBD, Biologic therapy, Conventional therapy, Infliximab, Adalimumab, PCDAI, PUCAI, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 10 Jan 2028 (estimated)
- First posted
- 14 Sep 2026 (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.
This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut University Children Hospital.
Detailed description
Pediatric-onset inflammatory bowel disease differs from adult-onset disease in phenotype, disease extent, and long-term prognosis. Conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators) and biologic therapy (mainly anti-TNFα agents) are used for induction and maintenance of remission.
This observational cohort study will include pediatric patients with confirmed Crohn's disease, ulcerative colitis, or IBD-unclassified. Patients will be classified into conventional therapy and biologic therapy groups. Clinical remission, response rates, steroid-free remission, adverse events, and growth parameters will be assessed over a 12-month period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | – | –Patients managed with 5-aminosalicylates, corticosteroids, and/or immunomodulators without biologic exposure during the observation period. |
| Biologic Therapy | – | –Patients who received biologic therapy (with or without concomitant conventional agents) during the observation period. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents up to 18 years of age with confirmed inflammatory bowel disease receiving conventional and/or biologic therapy at Assiut University Children Hospital and the Health Insurance IBD Committee, Assiut Branch.
Key inclusion criteria (5 listed)
- - Confirmed diagnosis of Crohn's disease, ulcerative colitis, or IBD-unclassified according to revised Porto criteria
- Age at diagnosis less than 18 years
- Receipt of conventional therapy and/or biologic therapy for a minimum evaluable treatment duration
- Availability of adequate medical records
- Written informed consent (for prospective component)
Key exclusion criteria (3 listed)
- - Incomplete medical records precluding assessment of primary endpoints
- Age more than 18 years
- Discontinuation of follow-up before a minimum evaluable treatment period
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
Clinical remission rate
Time frame: At week 8-12, 6 months, and 12 months
Proportion of patients achieving clinical remission at week 8-12, 6 months, and 12 months, defined as PCDAI ≤ 10 for Crohn's disease or PUCAI < 10 for ulcerative colitis.
5 secondary outcomes
Clinical response rate
Time frame: At week 8-12, 6 months, and 12 months
Steroid-free remission rate
Time frame: At 12 months
Incidence of adverse events
Time frame: Through 12 months
Change in growth parameters
Time frame: From baseline to 12 months
Treatment escalation or switch rate
Time frame: Through 12 months
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 14 Sep 2026.
- Background: PubMed 34995526Kuenzig ME, Fung SG, Marderfeld L, Mak JWY, Kaplan GG, Ng SC, Wilson DC, Cameron F, Henderson P, Kotze PG, Bhatti J, Fang V, Gerber S, Guay E, Kotteduwa Jayawarden S, Kadota L, Maldonado D F, Osei JA, Sandarage R, Stanton A, Wan M; InsightScope Pediatric IBD Epidemiology Group; Benchimol EI. Twenty-first Century Trends in the Global Epidemiology of Pediatric-Onset Inflammatory Bowel Disease: Systematic Review. Gastroenterology. 2022 Apr;162(4):1147-1159.e4. doi: 10.1053/j.gastro.2021.12.282. Epub 2022 Jan 5.
- Background: PubMed 29991879Sykora J, Pomahacova R, Kreslova M, Cvalinova D, Stych P, Schwarz J. Current global trends in the incidence of pediatric-onset inflammatory bowel disease. World J Gastroenterol. 2018 Jul 7;24(25):2741-2763. doi: 10.3748/wjg.v24.i25.2741.
- Background: PubMed 19913205Sauer CG, Kugathasan S. Pediatric inflammatory bowel disease: highlighting pediatric differences in IBD. Gastroenterol Clin North Am. 2009 Dec;38(4):611-28. doi: 10.1016/j.gtc.2009.07.010.
- Background: PubMed 18725221Van Limbergen J, Russell RK, Drummond HE, Aldhous MC, Round NK, Nimmo ER, Smith L, Gillett PM, McGrogan P, Weaver LT, Bisset WM, Mahdi G, Arnott ID, Satsangi J, Wilson DC. Definition of phenotypic characteristics of childhood-onset inflammatory bowel disease. Gastroenterology. 2008 Oct;135(4):1114-22. doi: 10.1053/j.gastro.2008.06.081. Epub 2008 Jul 3.
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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.
Nafisa H Abdel-Aziz, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Assiut University.
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 5 inclusion and 3 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 14 Sep 2026. 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 Elizabeth M lshak, Resident (01221541345, elithabeth.17289856@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: At week 8-12, 6 months, and 12 months). 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 NCT07818473, which also lists 4 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 14 Sep 2026.