The Intensive Post Exclusive Enteral Nutrition Study (iPENS): A Randomised Trial to Evaluate CD-TREAT Diet as a Food Reintroduction Regime in Children and Young Adults With Crohn's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 10
- 主要终点
- Colonic inflammation
研究概览
简要总结
Crohn's disease (CD) is a chronic inflammatory condition with phases where the disease is active and other, where there are no symptoms. Exclusive enteral nutrition (EEN), a liquid only diet without allowance of any extra food, is the main treatment for children with active CD. However, when children stop the liquid diet and return to their normal diet, most of them will experience an increase in their gut inflammation, mostly without symptoms initially. The aim of this study is to investigate this phenomenon by exploring if diet and gut bacteria play a role. Furthermore, the investigators aim to test whether a new, ordinary food-based diet, called the Crohn's Disease TReatment with EATing (CD-TREAT) diet can help control gut inflammation during the early food reintroduction phase, after EEN completion, compared to an unrestricted, free diet.
详细描述
A maximum of 60 participants, who have successfully responded to EEN, will be allocated to the study arms with block randomisation, with a 1:1 allocation, in random size blocks. The electronic randomisation process will be performed by an independent researcher. Those participants who do not wish to be randomised to one of the two study arms, will be offered the chance to be allocated to the group of their preference. Using this approach, inclusion of all eligible participants will be ensured, as excluding those who do not wish to be randomised, may reduce the generalisation of findings and minimise statistical power of a study with modest eligible population to recruit from.
CD-TREAT diet (intervention group)
Participants in the intervention group will consume the CD-TREAT diet exclusively without being allowed to consume additional food, for the first 3 weeks of food reintroduction, after EEN completion. They will be provided with a tailored, dietitian-devised diet, which has been designed to replicate the nutritional composition of EEN. The intervention will be overseen by qualified dietitians, including a National Health Service (NHS) research dietitian.
Unrestricted diet (control group)
Participants in the control group will consume a free, unrestricted diet for the same period, as the intervention group.
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
盲法说明
Electronic random block-size randomisation will be performed by a researcher not involved in study recruitment. Allocation to study arm will be revealed to participants after provision of informed consent.
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed or relapsing patients with active CD, who have shown clinical improvement by the 4th week of EEN treatment
排除标准
- •Administration of another induction treatment (e.g. corticosteroids, biologic agents).
- •Lack of clinical improvement with EEN treatment, as assessed by the clinical team.
- •Enrolment in other studies investigating the efficacy of novel therapies for maintenance or induction of remission.
- •Patients or families unable to provide written consent for participation in the study.
结局指标
主要结局
Colonic inflammation
时间窗: Baseline to 21 days post EEN completion
Comparison of faecal calprotectin levels between the intervention (CD-TREAT) and the control (unrestricted diet) group
次要结局
- Blood inflammatory markers(Baseline to 21 days post EEN completion)
- Quality of life(Baseline to 21 days post EEN completion)
- Diet and faecal microbiome(Baseline to 21 days post EEN completion)
- Diet and faecal metabolome(Baseline to 21 days post EEN completion)
- Crohn's Disease activity score(Baseline to 21 days post EEN completion)