Modulen IBD for Induction and Maintenance of Remission in Pediatric Crohn's Disease
September 10, 2026 updated by: MartinaEmad, Assiut University
Effectiveness of a Specially Prepared Medical Milk Formula for Induction and Maintenance of Remission in Pediatric Crohn's Disease
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.
Study Overview
Status
Not yet recruiting
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.
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Martina e Anwer, Resident
- Phone Number: 01229046462
- Email: martinaemad955@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study 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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Modulen group
Children with Crohn's disease receiving Exclusive Enteral Nutrition followed by Partial Enteral Nutrition with Modulen IBD.
|
|
Non-Modulen group
Children with Crohn's disease not receiving Modulen IBD formula.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical remission rate after exclusive enteral nutrition
Time Frame: 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.
|
At week 6-8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maintenance of remission
Time Frame: At 6 months and at 12 months
|
Proportion of patients remaining in clinical remission (PCDAI <10) at 6 months and 12 months
|
At 6 months and at 12 months
|
|
Change in weight
Time Frame: From baseline to week 6-8, 6 months, and 12 months
|
Change in body weight (kg) from baseline.
|
From baseline to week 6-8, 6 months, and 12 months
|
|
Change in BMI z-score
Time Frame: From baseline to week 6-8, 6 months, and 12 months
|
Change in Body Mass Index z-score from baseline.
|
From baseline to week 6-8, 6 months, and 12 months
|
|
Change in inflammatory markers
Time Frame: 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.
|
From baseline to week 6-8, 6 months, and 12 months
|
|
Relapse rate
Time Frame: Up to 12 months
|
Proportion of patients experiencing clinical relapse (PCDAI ≥10) during follow-up.
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Osama m El-Asheer, prof, pediatrics Department, Assiut University Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- van Rheenen PF, Aloi M, Assa A, Bronsky J, Escher JC, Fagerberg UL, Gasparetto M, Gerasimidis K, Griffiths A, Henderson P, Koletzko S, Kolho KL, Levine A, van Limbergen J, Martin de Carpi FJ, Navas-Lopez VM, Oliva S, de Ridder L, Russell RK, Shouval D, Spinelli A, Turner D, Wilson D, Wine E, Ruemmele FM. The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update. J Crohns Colitis. 2021 Feb 1;15(2):jjaa161. doi: 10.1093/ecco-jcc/jjaa161. Epub 2020 Oct 7.
- Trivedi PH, Gadhawe J, Salvi SM, Dodia SM, Pawar D, Patil AS. Stage-specific GWAS identifies a pleiotropic ankyrin repeat locus near GmSALT3 for salinity tolerance in soybean. Plant Cell Rep. 2026 Mar 16;45(4):93. doi: 10.1007/s00299-026-03779-9.
- Zhu X, Chen M, Dong Z, Liu Y, Mu Q, Basit F, Liu J, Hu J, Guan Y. Stress-associated protein OsSAP5 regulates rice heading date through interacting with OsGF14c in rice. Front Plant Sci. 2025 Sep 9;16:1589989. doi: 10.3389/fpls.2025.1589989. eCollection 2025.
- Kaspi E, Frankel D, Roll P. Lipid inclusions accumulation in macrophages from peritoneal effusion of a newborn. EJHaem. 2020 Oct 27;1(2):392-393. doi: 10.1002/jha2.124. eCollection 2020 Nov. No abstract available.
- Brindicci VF, Grieco R, Ruiz RG, Cardile S, Capriati T, Trovato CM, Bolasco G, Knafelz D, Bracci F, Alterio A, Ferretti F, Elia D, Spinetti E, Francavilla R, Diamanti A. Enteral Nutrition in Pediatric Crohn's Disease: New Perspectives. Nutrients. 2025 Sep 30;17(19):3124. doi: 10.3390/nu17193124.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 10, 2026
Primary Completion (Estimated)
September 10, 2027
Study Completion (Estimated)
January 20, 2028
Study Registration Dates
First Submitted
September 10, 2026
First Submitted That Met QC Criteria
September 10, 2026
First Posted (Actual)
September 16, 2026
Study Record Updates
Last Update Posted (Actual)
September 16, 2026
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Modulen-Pediatric-CD-Assiut-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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