Mediterranean Diet vs. Low Residue Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.
详细描述
The Mediterranean diet has been associated with anti-inflammatory properties and with decreased risk for several chronic diseases. However, the effect of Mediterranean diet has not been evaluated in patients with inflammatory bowel diseases.
The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.
Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age: 18-75
- •Diagnosis of Crohn's Disease
- •Montreal classification- B1
- •CDAI: 150-450 + CRP>0.5 or fecal calprotectin >200
- •Induction therapy with corticosteroids, 5-ASA, AZA, 6-MP, MTX or biologic therapy
- •Capacity to give informed consent
排除标准
- •Ileostomy or colostomy
- •Exclusive enteral nutrition/ partial enteral nutrition
- •History of or current severe systemic diseases
- •History of admission due to bowel obstruction
- •Positive Clostridium difficile toxin
- •Positive Salmonella, Shigella, Campylobacter, stool culture
- •Pregnancy or lactation
- •Use of antibiotics or steroids one month prior to inclusion
结局指标
主要结局
Crohn's Disease Activity Index (CDAI)
时间窗: 8 weeks
Change from baseline
次要结局
- Microbial composition(8 weeks)
- C-reactive protein(8 weeks)
- Fecal calprotectin(8 weeks)
- Remission rate- CDAI<150 + normal CRP/ fecal calprotectin(52 weeks)
- Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin(8 weeks)
研究者
michal roll
PhD
Tel-Aviv Sourasky Medical Center