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临床试验/NCT04913467
NCT04913467招募中不适用

Potential Effects of Ileocolonic Delivered Vitamins or the Groningen Anti-Inflammatory Diet on Course of Crohn's Disease and the Microbiome of Healthy Volunteers: a Randomized Controlled Trial - The Vita-GrAID Study

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2021年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
510
试验地点
2
主要终点
Change in faecal calprotectin

研究概览

简要总结

This study will evaluate if the Groningen Anti-Inflammatory Diet and the ileocolonic delivery of vitamin B2, B3 and C can positively influence the course of Crohn's disease and can positively alter the gut microbiome of Crohn's disease patients as well as healthy volunteers.

详细描述

It is becoming increasingly more well known that diet and the microbiome have a pivotal role in the development and course of inflammatory bowel diseases (IBD). Strict exclusive enteral nutrition (EEN) can induce remission in Crohn's Disease (CD) and is the standard treatment in paediatric CD. Implementing a restrictive diet in adults is difficult; adult patients do not tend to adhere to EEN. Recently, the CD-exclusion diet (CDED) combined with partial enteral nutrition demonstrated to be effective in CD-patients with flares.

Additionally, accumulating evidence suggests that intake of vitamins can influence disease course, mainly by beneficially modulating the gut microbiota and gut redox potential, especially if the vitamins can be delivered to the colon.

Nevertheless, no dietary guidelines are available to physicians and patients. Due to complaints of certain foods and patients' eagerness to postpone new flares, patients start experimenting with their food. As patients with CD are already often malnourished, this poorly substantiated experimenting puts them even more at risk for malnutrition and could have a potential negative effect on their disease outcomes. Next, quality of life of patients decreases and healthcare costs will rise. Therefore, both patients and physicians are in desperate need of evidence for an anti-inflammatory dietary advice in CD. As compliance to a diet increases when they are supported by family members, their household members will also be asked to participate in the study. Simultaneously studying their healthy family members will also provide information of the effect of this anti-inflammatory diet or intake of lieocolonic-delivered vitamins on their microbiome and markers of inflammation and oxidative stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in faecal calprotectin

时间窗: Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months

Primary outcome for CD patients

Change in microbiome composition measured by metagenomic sequencing- based profiles

时间窗: Faeces sample collection at 3 time points: At baseline (0 months), after 3 months, after 12 months

Primary outcome for healthy volunteers and CD patients

次要结局

  • The number of flares (defined as faecal calprotectin >200 μg/g and Crohn's Disease Activity Index (CDAI) ≥220 points)(Faeces sample collection and CDAI score determination at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months)
  • Improvements of Quality of life scores as assessed by Inflammatory Bowel Disease Questionnaire (Score range of 32-224, The higher the score the higher the Quality of Life)(Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months)
  • Improvements of Quality of life scores as assessed Food Related Quality of Life Questionnaire (Score range of 29-145, The higher the score the higher the Food related-Quality of Life)(Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months)
  • Adherence to the dietary interventions as assessed by a Dietary Compliance Questionnaire(Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. dr. G. Dijkstra

Clinical Professor, Head of Inflammatory Bowel Disease Center and Intestinal Transplantation Center

University Medical Center Groningen

研究点 (2)

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