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

N/ANot Yet RecruitingNCT07821645

Assiut University40 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Crohn Disease Inflammatory Bowel Diseases Pediatric Crohns Disease

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical remission rate after exclusive enteral nutrition

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.

Time frame: At week 6-8

Secondary Outcomes

Maintenance of remission

Proportion of patients remaining in clinical remission (PCDAI \<10) at 6 months and 12 months

Time frame: At 6 months and at 12 months

Change in weight

Change in body weight (kg) from baseline.

Time frame: From baseline to week 6-8, 6 months, and 12 months

Change in BMI z-score

Change in Body Mass Index z-score from baseline.

Time frame: From baseline to week 6-8, 6 months, and 12 months

Change in inflammatory markers

Change in C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and fecal calprotectin levels from baseline.

Time frame: From baseline to week 6-8, 6 months, and 12 months

Relapse rate

Proportion of patients experiencing clinical relapse (PCDAI ≥10) during follow-up.

Time frame: Up to 12 months

Central Contacts

Martina e Anwer, Resident

CONTACT

01229046462 martinaemad955@aun.edu.eg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.