Reduced Intestinal Motility in Inflammatory Crohn's Disease - Optimisation Studies in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Small bowel motility
研究概览
简要总结
Crohn's disease (CD) is becoming more common. One of the main features of this disease is weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems have a strong negative effect on the patients' quality of life but the causes of these problems are not well understood.
Enteroendocrine cells are nutrient sensors in the bowel that secrete special chemicals (called hormones) that control appetite and the movements all the gut. The investigators think that this control mechanism goes wrong in Crohn's patients and they have set off to do more research on this. Looking at the inside work of the gut has always been difficult and at times unpleasant for patients, however recent developments in magnetic resonance imaging (MRI) are allowing the investigators to study the workings of the gut in greater detail and without discomfort for the patients.
Before studying the Crohn's patients it is necessary to run a set of pilot experiments in healthy volunteers using a test meal and subsequent MRI imaging to look at the motion of the gut. This validation stage of the methodology is essential before embarking in more detailed studies in the patients.
详细描述
Background: Poor nutrition in Crohn's disease (CD) is common but poorly understood. Apart from disease burden and repeated surgery, reduction in appetite might be an aetiological factor.
Enteroendocrine cells (EC) are intraluminal nutrient sensors. They play a pivotal role in orchestrating physiological functions in the gastrointestinal tract. Sensing the nutrient content of the lumen, they secrete multiple peptides and amines that control gut secretory and motor functions. CD patients with small bowel inflammation show increased expression in EC peptides with exaggerated postprandial responses in anorectic EC hormones. This is associated with symptoms of nausea and anorexia, with EC-peptide expression decreasing to normality in remission.
There has been a longstanding interest on the effect of CD on gastric emptying and gastrointestinal motility.
Recent technological advances have allowed us to use magnetic resonance imaging (MRI) to measure both disease activity, intestinal motility and whole gut transit.
Reduced intestinal motility has been recently shown in CD patients with active terminal ileal disease. A significant negative correlation is observed between terminal ileal motility and histological, biochemical and radiological measures of disease activity. Intestinal hypomotility may be observed in proximal unaffected segments of small bowel as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI): 18-30 Kg/m2
排除标准
- •Patients with a history of inflammatory bowel disease.
- •A history of bowel resections or any gastric surgery.
- •History of pancreatic insufficiency, thyroid disease or/and diabetes.
- •Protein-pump inhibitor usage or any medication that affects gastric emptying or small bowel transit.
- •Any potential participants scoring very highly on the depression scale questionnaire.
- •Standard MRI exclusion criteria (e.g. pacemaker).
- •Malignant disease
- •Stricturing or penetrating disease
- •Smoking history
- •History of bowel resections or any gastric surgery
- •Significant cardiovascular or respiratory disease
- •Current Infection
- •Neurological or cognitive impairment
- •Significant physical disability
- •Significant hepatic disease or renal failure
- •Subjects currently (or in the last three months) participating in another research project
- •pregnancy or breastfeeding
结局指标
主要结局
Small bowel motility
时间窗: From fasting baseline to 270 min postprandially
MRI small bowel motility index (arbitrary units)
次要结局
- Gastric volumes(From fasting baseline to 150 min postprandially)
- Satiety(From fasting baseline to 270 min postprandially)
- Plasma GLP-1(From fasting baseline to 270 min postprandially)
- Whole gut transit(24 hours after ingestion of the MRI transit capsules)
- Plasma PYY(From fasting baseline to 270 min postprandially)
- Plasma CCK(From fasting baseline to 270 min postprandially)
- Gall bladder contraction(From fasting baseline to 60 min postprandially)
- Small bowel water content(From fasting baseline to 270 min postprandially)