Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Tolerance- Ability to remain on prescribed nutritional therapy
研究概览
简要总结
This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD).
Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8 -21 years old.
- •Diagnosis of Crohn's disease within 24 months
- •Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin
- •Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥
- •Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent.
排除标准
- •History of surgery for Crohn's disease.
- •Perianal disease as part of Crohn's disease phenotype.
- •Recent use of:
- •corticosteroids (within 4 weeks),
- •dose adjustment of immunomodulator (within 8 week)
- •azathioprine 4 weeks prior to study final visit (week 8)
- •start or adjust methotrexate 3 weeks prior to final study visit.
- •Prior use of biological medication
- •Prior treatment with EEN or other dietary therapy for Crohn's disease.
- •Prior treatment with antibiotics for Crohn's disease.
- •Known allergies to any of the food components in the smoothie.
- •Admission to hospital due to severity of Crohn's disease and associated symptoms.
- •Unwillingness to provide informed consent.
结局指标
主要结局
Tolerance- Ability to remain on prescribed nutritional therapy
时间窗: 4 and 8 weeks
Tolerance of therapy as measured by ability to continue prescribed nutritional therapy over 4-weeks and 8-weeks without deviation from protocol. Participants will meet with a study dietitian at week 2, week4, and week 8. Dietitians will evaluate caloric needs, specific deficits, and dietary limitations.
次要结局
- Fecal Calprotectin reduction from baseline(4 and 8 weeks)
- Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline(4 and 8 weeks)
研究者
Dale Lee
Associate Professor, Medical Director, Clinical Nutrition; Director of the Celiac Disease Program
Seattle Children's Hospital