Modulen IBD for Induction and Maintenance of Remission in Pediatric Crohn's Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
- Age 18 years or older
Severe complicated Crohn's disease requiring immediate surgery
Other chronic gastrointestinal diseases
Severe systemic illnesses affecting nutritional status
Trial population
Children and adolescents younger than 18 years with mild-to-moderate active Crohn's disease attending the Pediatric Gastroenterology, Hepatology and Clinical Nutrition Unit at Assiut University Children Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Modulen group
Group B: Non-Modulen group
Trial outcomes
Primary outcomes
1
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 6-8Secondary outcomes
1
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 months2
Change in weight
Change in body weight (kg) from baseline.
Time frame
From baseline to week 6-8, 6 months, and 12 months3
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 months4
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: