Modulen IBD for Induction and Maintenance of Remission in Pediatric Crohn's Disease

Effectiveness of a Specially Prepared Medical Milk Formula for Induction and Maintenance of Remission in Pediatric Crohn's Disease

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07821645

Enrollment

Registered

2026-09-16

Start date

2026-09-10

Completion date

2028-01-20

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Inflammatory Bowel Diseases, Pediatric Crohns Disease

Keywords

Modulen IBD, Exclusive enteral nutrition, Pediatric Crohn's disease, PCDAI, Remission

Brief summary

This prospective cohort study aims to evaluate the effectiveness of the specially prepared medical milk formula (Modulen IBD) in inducing and maintaining remission in children and adolescents with Crohn's disease at Assiut University Children Hospital.

Detailed description

Exclusive Enteral Nutrition (EEN) is recommended as first-line therapy for induction of remission in mild-to-moderate pediatric Crohn's disease. Modulen IBD is a polymeric formula enriched with TGF-β2. This observational study will include children and adolescents younger than 18 years with mild-to-moderate active Crohn's disease. Patients receiving Modulen IBD for Exclusive Enteral Nutrition followed by Partial Enteral Nutrition will be compared with those not receiving the formula. Clinical remission, nutritional status, growth parameters, and laboratory markers will be assessed at predefined time points up to 12 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

Inclusion criteria

* \- Age younger than 18 years * Diagnosis of Crohn's disease according to clinical, endoscopic, histopathological, and radiological findings * Mild to moderate active Crohn's disease * Newly diagnosed or active patients commencing Exclusive Enteral Nutrition therapy * Written informed consent from parents or legal guardians

Exclusion criteria

* \- Age 18 years or older * Severe complicated Crohn's disease requiring immediate surgery * Other chronic gastrointestinal diseases * Severe systemic illnesses affecting nutritional status * Inability to tolerate enteral nutrition * Poor compliance with Modulen therapy * Incomplete follow-up data

Design outcomes

Primary

Measure	Time frame	Description
Clinical remission rate after exclusive enteral nutrition	At week 6-8	Proportion of patients achieving clinical remission defined as Pediatric Crohn's Disease Activity Index (PCDAI) score less than 10 after 6-8 weeks of Exclusive Enteral Nutrition with Modulen IBD.

Secondary

Measure	Time frame	Description
Maintenance of remission	At 6 months and at 12 months	Proportion of patients remaining in clinical remission (PCDAI \<10) at 6 months and 12 months
Change in weight	From baseline to week 6-8, 6 months, and 12 months	Change in body weight (kg) from baseline.
Change in BMI z-score	From baseline to week 6-8, 6 months, and 12 months	Change in Body Mass Index z-score from baseline.
Change in inflammatory markers	From baseline to week 6-8, 6 months, and 12 months	Change in C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and fecal calprotectin levels from baseline.
Relapse rate	Up to 12 months	Proportion of patients experiencing clinical relapse (PCDAI ≥10) during follow-up.

Contacts

CONTACTMartina e Anwer, Resident

martinaemad955@aun.edu.eg01229046462

STUDY_CHAIROsama m El-Asheer, prof

pediatrics Department, Assiut University Hospitals

Outcome results