The Feasibility of Following the Crohn's Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of following the Crohn's Diet: questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •will include:
- •Adults aged ≥18 years with a diagnosis of Crohn's disease
- •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).
- •Individuals with a Body Mass Index (BMI) of ≥ 18.5 kg/m2
- •Individuals able to give informed consent
- •Individuals able to understand and read English
- •Individuals willing to provide consent in this study which involves a dietary change for 14 days
排除标准
- •will include:
- •Unexplained/unintentional weight loss in the past 6 months
- •Major co-morbidities; for example, diabetes, coeliac disease, major active psychiatric conditions or current eating disorders.
- •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.
- •Individuals who report to be pregnant or lactating
- •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.
结局指标
主要结局
Feasibility of following the Crohn's Diet: questionnaire
时间窗: 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.
次要结局
- Impact of the Crohn's Diet on gastrointestinal symptoms(One week before the intervention and within one week of completing the 14-day intervention)
- Acceptability of following the Crohn's Diet: questionnaire(Throughout the 14-day intervention and within one week of completing the intervention)
- Impact of the Crohn's Diet on habitual dietary intake(One week before the intervention and throughout the 14-day intervention)
- Impact of the Crohn's Diet on BMI(One week before the intervention and within one week of completing the 14-day intervention)
- Participant compliance to the Crohn's Diet(Throughout the 14-day intervention)
- Impact of the Crohn's Diet on perceived disease control(One week before the intervention and within one week of completing the 14-day intervention)