The Feasibility of Following the Crohn's Diet
追踪信息 | |||
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首次提交日期 ICMJE | September 20, 2018 | ||
首次发布日期e ICMJE | October 1, 2018 | ||
最后更新发布日期 | October 1, 2018 | ||
预计研究开始日期 ICMJE | July 8, 2018 | ||
预计主要完成日期 | February 1, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Feasibility of following the Crohn's Diet: questionnaire[ Time Frame: Throughout the 14-day intervention ] Method: Collation of participant feedback during the Crohn's Diet and administer diet feasibility questionnaire. This questionnaire uses an adapted Education Method Usability Scale (Bangor et al. 2008) ('strongly agree' to 'strongly disagree' style scale) and open questions. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | The Feasibility of Following the Crohn's Diet | ||
正式标题 ICMJE | The Feasibility of Following the Crohn's Diet | ||
简要概况 | A research team from King's College London are investigating how diet can be used as a treatment for Crohn's disease. The investigators have designed a new diet and eventually wish to test whether the diet can be used to manage Crohn's disease and reduce gut inflammation. Before doing this, the investigators need to find out how practical it is for people to follow the diet for 14 days by conducting this 'feasibility' study. A feasibility study is a small study that aims to highlight any issues before informing the design of a larger research trial. The diet the investigators have designed is called the Crohn's Diet. The evidence for this diet is based on recent research which suggests that certain food ingredients may be involved in triggering gut inflammation. The study's primary aim is to assess the practicalities of following the Crohn's Diet. It will also assess compliance to the Crohn's Diet and if following it changes the nutritional balance from the normal diet. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Non-Randomized 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Other |
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适用条件 ICMJE | |||
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研究工具 |
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招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
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原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | March 1, 2019 | ||
预计主要完成日期 | February 1, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria will include: 1. Adults aged ≥18 years with a diagnosis of Crohn's disease 2. Stable Crohn's disease (as defined as self-reported: no change in Crohn's disease medication in the last 3 months; no Crohn's disease surgery in the last 6 months; no hospital admissions related to Crohn's disease in the last 6 months; no new perianal Crohn's disease in the last 6 months). 3. Individuals with a Body Mass Index (BMI) of ≥ 18.5 kg/m2 4. Individuals able to give informed consent 5. Individuals able to understand and read English 6. Individuals willing to provide consent in this study which involves a dietary change for 14 days Exclusion Criteria will include: 1. Unexplained/unintentional weight loss in the past 6 months 2. Major co-morbidities; for example, diabetes, coeliac disease, major active psychiatric conditions or current eating disorders. 3. Current Crohn's disease therapy with any of the following: corticosteroids, exclusive or partial enteral nutrition (liquid nutrition), and any participants prescribed oral nutrition supplements for nutrition support. 4. Individuals who report to be pregnant or lactating 5. Individuals with specific, complex dietary needs (based on the dietitian's judgment), such as multiple food allergies, in which the additional burden of the Crohn's Diet would pose a nutrition risk. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United Kingdom | ||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | King's College London | ||
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研究员 ICMJE |
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验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |