Confocal Endomicroscopy for the Detection of Food Intolerances in Patients With IBS: Add on Control Group: Does Stress Cause Similar Mucosal Changes to Food Antigens?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.
研究概览
简要总结
After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation.
Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa.
Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space.
Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers.
The procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1.
Samples taken are the same amount as done in the previous food associated study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Age >18 years
- •No abdominal symptoms such as bloating and abdominal pain
- •Barrett's esophagus
- •Independent indication for confocal laser endomicroscopy for evaluation of Barrett's dysplasia
- •Written informed consent for participation in this study
排除标准
- •Any known other gastrointestinal disease including infection such as helicobacter pylori, Morbus Whipple or others, celiac disease, or chronic inflammatory bowel disease
- •Active or recent GI Bleeding
- •Stricture in the upper gastrointestinal tract
- •Impaired renal function (Creatinine >1.2 mg/dL)
- •Pregnancy or breast feeding
- •Inability to obtain informed consent
- •Known allergy to Methylene blue or Fluorescein
- •Participation in other clinical trials within the last 4 weeks
研究组 & 干预措施
Stress
Injection of corticotropin releasing factor
干预措施: Stress (Drug)
Control
Injection of 0.9% saline 10 ml
干预措施: Control (Drug)
结局指标
主要结局
visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.
时间窗: immediate
次要结局
未报告次要终点
研究者
Mark Ellrichmann
Senior Consultant, Unit of Experimental Endoscopy
University Hospital Schleswig-Holstein
