Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 8
- 主要终点
- ITT, steroid free Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 14
研究概览
简要总结
The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.
详细描述
Rational: Exclusive enteral nutrition (EEN) is an established but difficult to perform method for induction of remission and cannot be used for maintenance of remission. It entails drinking only liquid formula for 8 weeks. Refusal to use or to adhere to this therapy is not uncommon and leads to use of other non- dietary strategies in children including steroids and immunosuppression. The Crohn's Disease Exclusion Diet (CDED) with partial enteral nutrition has been shown to be effective for children with mild to moderate disease. The investigators have developed a maintenance strategy using the CDED.
Objectives: To prove that induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of EEN with Modulen and 12 weeks of an exclusion diet involving selected table foods.
Methods: Open label randomized controlled pilot trial comparing two weeks of EEN followed by the CDED and Partial Enteral Nutrition (PEN), to 8 weeks of EEN followed by PEN with free diet. The study will include a control group of healthy children for microbiome studies.
Population: Age 8-18 years with mild to severe active Crohn's disease defined as 15≤Pediatric Crohn's Disease Activity Index (PCDAI)<47.5.
Time frame: The induction of remission phase will last 8 weeks followed by maintenance phase for a period of 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with very mild disease (PCDAI 12.5 -15) or very severe disease (PCDAI >47.5)
- •Patients who have disease confined to the colon involving the descending colon, rectum or sigmoid colon and no prior history of small bowel involvement
- •Patients who have active extra intestinal disease (such as Arthritis, Uveitis, Pyoderma Gangrenosum, Erythema Nodosum etc.)
- •Patients with complicated disease (B2, B3)
- •Patients who recently onset use of an immunomodulator <8 weeks, or dose change in past 8 weeks.
- •Patients with current use of biologics, or use in last 8 weeks or current use of systemic steroids
- •Patients who have active perianal disease ( active fistula or abscess)
- •Patients who have positive stool cultures with relevant pathogens,, or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
- •Patients with fever > 38.3
- •Documented milk protein allergy
结局指标
主要结局
ITT, steroid free Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 14
时间窗: week 14
Sustained remission with EEN Vs CDED+PEN
次要结局
- Microbiome composition difference between groups at week 14(week 14)
- Steroid and biologic free sustained remission at week 24.(week 14 and 24)
- Need for additional treatment to achieve remission by week 14(Week 14)
- Mucosal healing as assessed by MRE in dietary responsive disease at week 52(Week 52)
- ITT steroid free remission at week 8(week 8)
- 3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for patients on original treatment(week 24)
研究者
Prof. Arie Levine
Director, Pediatric Gastroenterology and Nutrition unit
Wolfson Medical Center