An observational study in Crohn Disease, Inflammatory Bowel Diseases and Pediatric Crohns Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Assiut University · Observational
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.
1,992 studies on the registry are indexed under Crohn Disease; 477 are open to participants now.
This study's planned enrollment of 40 is below the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children with Crohn's disease receiving Exclusive Enteral Nutrition followed by Partial Enteral Nutrition with Modulen IBD.
Children with Crohn's disease not receiving Modulen IBD formula.
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
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
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 231 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's planned 12 months is below that.
Counting every sponsor, half of 304 studies reached it within 41 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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