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临床试验/NCT01756963
NCT01756963已完成不适用

Diet and Disease Activity in Patients With Inflammatory Bowel Disease

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
273
试验地点
1
主要终点
The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients

研究概览

简要总结

In addition to a genetic susceptibility, the immune system and the intestinal microbiota, diet is hypothesized to be an important factor in the onset and progression of Inflammatory Bowel Diseases (IBD). Further insight in factors affecting disease activity may contribute to targeted interventions improving disease burden and healthcare costs for these patients. However, well-designed studies exploring the role of diet in the development of exacerbations are hardly available.

The investigators hypothesize that differences in dietary patterns affects the intestinal microbiota composition and thereby contributes to the development of exacerbations in IBD.

Furthermore, a subgroup of patients suffers from malnutrition, although the exact prevalence is unknown since simple noninvasive screening tools have not been validated for IBD. The investigators hypothesize that malnutrition is frequently present in IBD patients and associated with dietary intake and disease characteristics.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • IBD patients, diagnosis based on clinical, endoscopic, histological and/or radiological criteria
  • participating IBD-SL cohort

排除标准

  • Unable to provide informed consent

结局指标

主要结局

The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients

时间窗: 2 years

次要结局

  • To characterize intestinal microbiota in IBD patients with different dietary patterns(2 years)
  • To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up(2 years)
  • To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up(2 years)
  • To study the prevalence of malnutrition in a consecutive cohort of IBD outpatients(1 year)
  • The study the association of disease characteristics and dietary intake with the prevalence of malnutrition in a consecutive cohort of IBD outpatients(1 year)
  • To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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