Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Intestinal inflammation
研究概览
简要总结
Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. CD is a common inflammatory bowel disease (IBD), frequent (150,000 patients in France and 1.5 million in Europe), disabling and incurable. The environmental factors, and in particular diet, play a major role in the pathogenesis of CD. The prevalence of CD is steadily increasing in highly industrialized countries, where the Western diet rich in saturated fats and refined sugars, is blamed for this to explain this true pandemic. On the other hand, enteral nutrition, exclusive or partial, is known to be effective in the initial treatment of CD, especially in pediatrics.
There are a number of evidence in favor of a nutritional management nutritional management of caloric restriction during inflammatory diseases such as psoriasis and rheumatoid arthritis,whose physiopathology is similar to that of IBD.
To date, and despite patient concern, there is no consensus nutritional in the management of CD to influence the natural course of the disease.
The investigators have decided to initiate a clinical study to evaluate for the first time the efficacy, acceptability and safety of intermittent caloric restriction in patients with CD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 to 65 years old
- •Established diagnosis of Crohn's disease with a minimum disease duration of 3 months
- •Patient with mild to moderate Crohn's disease defined by a fecal calprotectin ≥ 250 μg/g and a CDAI score between 150 to 300
- •Medical treatment of Crohn's disease stable for at least 3 months
- •Patient compliant with an intermittent caloric restriction during 16 weeks
- •Person affiliated to or beneficiary of a social security plan
- •Person informed about study organization and having signed the informed consent
排除标准
- •Patient with a BMI < 18.5kg/m2
- •Patient having a weight loss of 5% the first month and 10% during the first 6 months
- •Patient with active ano-perineal lesions
- •Patient with an ostomy
- •Patient with eating disorders (anorexia, bulimia)
- •Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:
- •Pregnant, parturient or breastfeeding woman
- •Minor person (non-emancipated)
- •Adult person under legal protection (any form of public guardianship)
- •Adult person incapable of giving consent and not under legal protection
- •Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
结局指标
主要结局
Intestinal inflammation
时间窗: week 16
Evaluate the effectiveness of personalized nutritional management of intermittent caloric restriction during 16 weeks on the level of intestinal inflammation (induction of of a biological response) in patients with mild to moderate CD mild to moderate. The effectiveness will be evaluated in each group by a biological response change, that is to say a decrease at least 50% of calprotectin fecal level.
次要结局
- Induction of a clinical response(week 16)
- Induction of a radiological response(week 16)
- Improving quality of life(week 16)
- Improving work productivity(week 16)
- Improving fatigue(week 16)
- Induction of a clinical remission(week 16)
- Induction of a biological remission(week 16)
- Improving functional disability(week 16)
- Improving anxiety disorder(week 16)
- Evaluate the safety of intermittent caloric restriction in patients with mild to moderate with mild to moderate CD.(weeks 4;8;12 and 16)
- Evaluate compliance of intermittent caloric restriction during 16 weeks in patients with with mild to moderate CD.(week 16)
- Determine the level of patient satisfaction with intermittent caloric restriction(week 16)
- Estimate, in the experimental arm, the prevalence of compensatory hyperphagia after intermittent caloric restriction(48 hours after intermittent caloric restriction)
研究者
CARON Bénédicte
Doctor
Central Hospital, Nancy, France