"Effect of capsaïcin Infusion on Esophageal Mucosal Integrity - a Role for TRPV1-mediated Neuropeptides?"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Changes in mucosal integrity in the distal exposed esophagus during capsaicin infusion compared to control solution.
研究概览
简要总结
Reflux is common, especially after large meals. In general, this can do no harm. However, if reflux occurs often and causes troublesome symptoms and or complications, it is called gastroesophageal reflux disease (GERD). Long exposure to gastric acid causes the mucosa of the esophagus to loose its integrity, which is thought to lead to the symptom of heartburn. Several food products can also impair the esophageal mucosa integrity and thereby influence reflux symptoms. One of these products is capsaicin, the pungent ingredient of red peppers. Use of capsaicin often leads to worsening of complaints in patients with GERD and can cause symptoms in healthy volunteers, possibly due to its effect on the mucosal integrity.
In this study the investigators want to investigate the effect of capsaicin infusion on mucosal integrity. The investigators will evaluate mucosal impedance and the histology of the esophageal mucosa. In addition, the investigators also aim to assess the involvement of the TRPV1 receptor by evaluating the possible release of neuropeptides in the esophageal mucosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of gastrointestinal disease, especially gastro-esophageal reflux disease.
- •BMI = 18-25 kg/m²
- •Caucasian race
- •Subject signed the informed consent form and is able to adhere to study protocol
排除标准
- •Age <18 years
- •Erosive esophagitis or gastric ulceration during endoscopy on PPI in the past or during the experiment
- •Use of regular (> 1 x per week) dietary capsaïcin (in additives as Tabasco/sambal/chili sauce or Indian, Mexican or Thai food dishes)
- •Allergy to capsaïcin
- •Use of medication affecting GI function (prokinetics) or antisecretory medication (PPI) within 3 days prior to endoscopy.
- •Multisystem diseases (including severe cardiopulmonary disease, collagen diseases, coagulation disorders)
- •Esophageal motility disorders
- •Previous esophageal or gastric surgery
- •Use of anticoagulants or a history of coagulopathy
- •Pregnancy
- •History of alcohol abuse or current excessive alcohol consumption (> 2 alcoholic beverages per day or > 14 alcoholic beverages per week)
结局指标
主要结局
Changes in mucosal integrity in the distal exposed esophagus during capsaicin infusion compared to control solution.
时间窗: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
The primary outcome measure is the effect of capsaïcin infusion on mucosal integrity as reflected by baseline impedance in the distal exposed esophagus compared to control infusion. We hypothesize that capsaïcin infusion induces changes to the mucosa as reflected by a decrease in baseline impedance.
次要结局
- TRPV1 neuropeptide pathway(Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy)
- Induction of dilated intercellular spaces (DIS)(Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy)
- Mucosal integrity in the proximal non-exposed esophagus.(Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy)
- Immunohistochemical expression of TRPV1(Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy)
- Symptom scores(Testday 1 and 2: during capsaicin and placebo infusion.)