Reduced Intestinal Motility in Inflammatory Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Primary Outcome Measure: MRI small bowel motility index (arbitrary units)
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.
Our main objective is to investigate the difference in small bowel motility between CD patients with active ileal disease and healthy volunteers.
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 and intestinal motility.
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.
An increase in EC activity could potentially lead to altered appetite and symptoms of nausea through delayed gastric emptying and most importantly delayed small bowel transit. This mechanistic link has not been described and present findings have not been correlated to patient symptoms. This work can potentially open a new therapeutic pathway in CD therapy. Optimisation studies in healthy volunteers (HV) are urgently needed.
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
- 否
入选标准
- •patients with active Cronh's disease
- •Body Mass Index (BMI): 18-30 Kg/m2
排除标准
- •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
研究组 & 干预措施
Feeding
Test soup meal feeding intervention
干预措施: Test soup meal feeding intervention (Other)
结局指标
主要结局
Primary Outcome Measure: MRI small bowel motility index (arbitrary units)
时间窗: From fasting baseline to 270 min postprandially
MRI small bowel motility index (arbitrary units)
次要结局
- Gall bladder contraction(From fasting baseline to 60 min postprandially)
- Gastric volumes(From fasting baseline to 150 min postprandially)
- Small bowel water content(From fasting baseline to 270 min postprandially)
- Plasma GLP-1(From fasting baseline to 270 min postprandially)
- Plasma PYY(From fasting baseline to 270 min postprandially)
- Plasma CCK(From fasting baseline to 270 min postprandially)
- Satiety: satiety VAS scores(From fasting baseline to 270 min postprandially)
- MaRIA score(360 min postprandially)