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NCT Number: NCT07821645

Modulen IBD 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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pediatric Crohn's disease Pediatric Crohns Disease

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Change in weight

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

    Change in body weight (kg) from baseline.

  3. 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.

  4. 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.

  5. Relapse rate

    Time frame: Up to 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Martina e Anwer, Resident

CONTACT

[email protected]

01229046462

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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