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临床试验/NCT02551289
NCT02551289已完成不适用

MRI Assessment in Newly Diagnosed Coeliac Disease and Following Gluten-free Diet Treatment

University of Nottingham1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年1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
72
试验地点
1
主要终点
Fasting small bowel water content (SBWC)

研究概览

简要总结

One in 100 people suffers from coeliac disease. It affects the lining of the bowel and causes many symptoms such as diarrhoea, wind, stomach pain, constipation and nausea. The only treatment so far is a strict glutenfree diet for life which reverses the bowel damage and often improves symptoms. Up to 25% of patients however may have persistent symptoms despite the gluten free diet but the reasons for this are not clear.

This research aims to help us understand how the gluten free diet works. Investigators will use medical imaging (magnetic resonance imaging or MRI) to measure the volumes of fluid in the small bowel, the size of the large bowel and the time it takes for foods to go through the entire bowel in patients who have just been diagnosed with coeliac disease by their hospital doctor. Investigators will also carry out a breath test and collect a stool sample for basic analysis of the stool bacteria.

Investigators will also collect questionnaires about their feelings and their bowel habits and will try to see how the MRI measurements relate to the patients' symptoms. Investigators will observe how all these measures change after one year of the gluten free diet that doctors will have prescribed as part of the coeliac patients' standard care. As such there is no dietary intervention in this study, investigators will simply study changes in the patients due to their standard treatment. Investigators will also look at a matched group of healthy volunteers to gather a likely reference range of the measurements. This research will be carried out in Nottingham with the help of the specialist coeliac clinics and it will last 3 years. There is a dedicated Coeliac Patient Public Involvement group who have helped plan this study.

详细描述

Hypotheses of the study

Based on the investigators' pilot data and on the literature available, this study aims to test the main hypotheses that in adults newly diagnosed with coeliac disease treatment with GFD will:

  1. reduce the water content of the fasting small bowel
  2. reduce the volume of the fasting colon
  3. increase whole gut transit time

Objectives of the study

The specific objectives of the study are therefore to quantify any change following treatment with a gluten-free diet (GFD) in:

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 65 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

Fasting small bowel water content (SBWC)

时间窗: 12 months

Fasting small bowel water content (SBWC) measured in ml approximately 12 months after initiation of GFD

次要结局

  • Colon volume(12 months after initiation of gluten free diet)
  • Gut transit time(12 months after initiation of gluten free diet)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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