Effectiveness of a Specially Prepared Medical Milk Formula for Induction and Maintenance of Remission in Pediatric Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Clinical remission rate after exclusive enteral nutrition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- 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
研究组 & 干预措施
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.
结局指标
主要结局
Clinical remission rate after exclusive enteral nutrition
时间窗: 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.
次要结局
- Maintenance of remission(At 6 months and at 12 months)
- Change in weight(From baseline to week 6-8, 6 months, and 12 months)
- Change in BMI z-score(From baseline to week 6-8, 6 months, and 12 months)
- Change in inflammatory markers(From baseline to week 6-8, 6 months, and 12 months)
- Relapse rate(Up to 12 months)
研究者
MartinaEmad
Resident Physician
Assiut University