ClinicalTrials.gg
Not yet recruitingNCT07818473Updated Sep 14, 2026

Conventional vs Biologic Therapy in Pediatric IBD

An observational study in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
Up to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 45 studies in Inflammatory Bowel Diseases by Assiut University — 20 open to participants now, 20 under way, none of them phase 3. Inflammatory Bowel Diseases · Assiut University.

Planned enrollment
13th of 41
100 · median 100
Started
2026
with 11 others
Observational
41 of 45
19 open now
Primary completion
2027-09
later than 11 of 19 live
Registered
42nd of 45
by date

Among the 45 studies in Inflammatory Bowel Diseases by Assiut University, this one is the 13th largest by planned enrollment of the 41 observational ones that give a count, is one of 12 that started in 2026, is one of 41 observational ones, reaches primary completion later than 11 of the 19 other live ones, and was the 42nd registered.

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.

Browse Inflammatory Bowel Diseases studies →

Open to participants now

20 of the 45 studies in Inflammatory Bowel Diseases by Assiut University are open now, in 1 country. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 20 open studies →

Where they have run

Who these studies take

Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.

This study: Up to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 45 studies in Inflammatory Bowel Diseases by Assiut University, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Ulcerative Colitis

Keywords

  • Pediatric IBD
  • Biologic therapy
  • Conventional therapy
  • Infliximab
  • Adalimumab
  • PCDAI
  • PUCAI
  • Assiut
04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - 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 (for prospective component)

Exclusion criteria

Exclusion Criteria:

  • - Incomplete medical records precluding assessment of primary endpoints
  • Age more than 18 years
  • Discontinuation of follow-up before a minimum evaluable treatment period
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At week 8-12, 6 months, and 12 months

Secondary outcomes

  1. 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).

    Time frame: At week 8-12, 6 months, and 12 months

  2. Steroid-free remission rate

    Proportion of patients in clinical remission without systemic corticosteroid use.

    Time frame: At 12 months

  3. Incidence of adverse events

    Proportion of patients experiencing adverse events (infusion/injection reactions, infections, hematologic abnormalities, hepatotoxicity), graded according to CTCAE-adapted criteria

    Time frame: Through 12 months

  4. Change in growth parameters

    Change in height z-score, weight z-score, and BMI z-score from baseline.

    Time frame: From baseline to 12 months

  5. Treatment escalation or switch rate

    Proportion of patients requiring treatment escalation or switching between conventional and biologic agents.

    Time frame: Through 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 34995526 ↗
  • Sykora 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 29991879 ↗
  • Sauer 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 19913205 ↗
  • Van 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 243 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 132. This study's planned 12 months is below that.

Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 14, 2026
StartEst.
Sep 10, 2026
Primary completionEst.
Sep 10, 2027
CompletionEst.
Jan 10, 2028
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07818473
Lead sponsor
Assiut University
Responsible party
Elizabeth Makar Ishak (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 14, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Sep 10, 2027 (estimated)
Completion
Jan 10, 2028 (estimated)
Last update
Sep 14, 2026

Study contacts

Elizabeth M lshak, Resident
Contact
elithabeth.17289856@med.aun.edu.eg
01221541345
Nafisa H Abdel-Aziz, prof
study chair · Pediatrics Department, Assiut University Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion