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Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease

NCT ID: NCT06742606

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-12-13

Brief Summary

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Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.

Detailed Description

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IBD are multifactorial disorders characterized by chronic relapsing intestinal inflammation (Fousekis et al .,2021). Main subtypes of pediatric IBD are Crohn's disease (CD), ulcerative colitis (UC), and IBD unclassified (Corica \& Romano .., 2017) Mechanism of IBD involves uncontrolled immune mediated inflammatory response in genetically predisposed individuals to an unknown environmental trigger that interacts with gut microbiome and primarily affects gastrointestinal tract ( Iyer \& Corr ..,2021) Pediatric onset IBD is more aggressive and rapidly progressive disease compared to adult onset IBD. Nearly a quarter of all patients with IBD develop this disease during childhood (Moon .., 2019), mean age at diagnosis ranged from 4.5 to 16 years in pediatric cases (Mosli et al ..,2021) Rates of pediatric onset IBD continue to rise around the world (Kuenzig et al ..,2022 ).

In2018, the highest annual incidences of pediatric IBD were 23/100000 person in Europe, 15.2/100000 in North America, and 11.4/100000 in Asia/ Middle East and Oceania (Sýkora et al .., 2018) Pediatric IBD management and therapeutic approach can be chall enging, especially in younger patients (Romeo et al .., 2020 )). Biologic agents have revolutionized the treatment paradigm of pediatric IBD (Kapoor \& Crowley ..,2021) Biological drugs are monoclonal antibodies target specific cytokines involved in inflammatory cascade, such as tumour necrosis factor alpha (TNFα), integrins or interleukin 12/23, and have been approved for both pediatric CD and UC (Romeo et al 2020)

Conditions

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Effect of Drug

Keywords

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biological therapy , IBD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients diagnosed as IBD

Inclusion Criteria:

1. Age: patients diagnosed as IBD aged from 1 month to 16 years
2. Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings (Levine et al, 2014).
3. Patients initially severely diseased or in relapse and planned to start or change biological therapy.

Exclusion Criteria:

1. Patients already on biological therapy and controlled.
2. Patients with known humeral or cell mediated immunodeficiency.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients diagnosed as IBD aged from 1 month to 16 years

study will include 2 groups of pediatric IBD patients planned to start biological treatment or change to other biological therapy and each group formed of 20 patients Group

1 of patients will receive Adalimumab while Group 1 will receive ustekinumab

Group Type EXPERIMENTAL

Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab

Intervention Type BIOLOGICAL

All the patients will be treated according to guidelines of ECCO/ESPGHAN and will be followed up regularly for 12 months by assessment

• response to treatment Frequency of relapses,

Regular assessment will be:

Clinically every 2 to 4 weeks at gastroenterology outpatient clinic by using activity scoring systems:

pediatric Ulcerative Colitis Activity Index pediatric Chron's Disease Activity Index

Laboratory follow up will done at weeks 12,24,36,48 of starting or changing to other biological by doing inflammatory markers( CBC, ESR, CRP, albumin. At the end of study(week 48) each patient will be reassessed by:

Disease activity:

Laboratory Endoscopy will be repeated at week 48 of starting or changing to other biological to assess effect of biologicals on reach mucosal healing.

Interventions

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Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab

All the patients will be treated according to guidelines of ECCO/ESPGHAN and will be followed up regularly for 12 months by assessment

• response to treatment Frequency of relapses,

Regular assessment will be:

Clinically every 2 to 4 weeks at gastroenterology outpatient clinic by using activity scoring systems:

pediatric Ulcerative Colitis Activity Index pediatric Chron's Disease Activity Index

Laboratory follow up will done at weeks 12,24,36,48 of starting or changing to other biological by doing inflammatory markers( CBC, ESR, CRP, albumin. At the end of study(week 48) each patient will be reassessed by:

Disease activity:

Laboratory Endoscopy will be repeated at week 48 of starting or changing to other biological to assess effect of biologicals on reach mucosal healing.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Patients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings.

Patients initially severely diseased or in relapse and planned to start or change biological therapy.

Exclusion Criteria

Patients already on biological therapy and controlled. Patients with known humeral or cell mediated immunodeficiency.

Ethical
Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Mohamed nageh abdelhamed, master degree in pediatrics

Role: CONTACT

Phone: [email protected]

Other Identifiers

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biological therapy and IBD

Identifier Type: -

Identifier Source: org_study_id