To investigate the effect of capsaicin infusion on mucosal integrity. We will evaluate mucosal impedance and the histology of the esophageal mucosa. In addition, we also aim to assess the involvement of the TRPV1 receptor by evaluating the possible…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline impedance as measured in vivo after infusion with capsaicin and
control solution.
Secondary outcome
1. Intercellulair spaces using electron microscopy ruimte met elektronen
microscoop
2. Mucosal concentration of neuropeptides
3. Immunohistochemical expression of TRPV1
4. VAS scores for heartburn, retrosternal pain.
Background summary
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.
Study objective
To investigate the effect of capsaicin infusion on mucosal integrity. We will
evaluate mucosal impedance and the histology of the esophageal mucosa. In
addition, we also aim to assess the involvement of the TRPV1 receptor by
evaluating the possible release of neuropeptides in the esophageal mucosa.
Study design
The study design is a randomized, cross-over study with two different
interventions (capsaicin/control infusion) in healthy volunteers.
Intervention
Capsaicin infusion and control infusion.
Study burden and risks
The subjects will perceive mild discomfort during the placement of the infusion
catheter. During the infusion period with capsaicin, subjects may perceive some
degree of heartburn, retrosternal pain, epigastric burning or nausea. These
symptoms will subside quickly after terminating the infusion. Allergies for
capsaicin will be actively inquired during screening. No side effects are
expected with the infusion of the control solution.
Endoscopy with biopsy taking
During endoscopy with biopsy taking, there is a small risk of perforation or
bleeding. Side effects from upper endoscopy are uncommon. Patients might have a
slightly sore throat after the procedure and air may be trapped in the stomach
causing a bloated feeling. These complaints usually clear up quite quickly
after the procedure.
Finally, participation takes time. We estimate that subjects will have to
invest 4 hours to participate.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects
I. No history of gastrointestinal disease, especially gastro-esophageal reflux disease.
II. BMI <= 18-25 kg/m²
III. Caucasian race
IV. Subject signed the informed consent form and is able to adhere to study protocol
Exclusion criteria
Healthy subjects
I. Age <18 years
II. Erosive esophagitis or gastric ulceration during endoscopy on PPI in the past or during the experiment.
III. Use of regular (> 1 x per week) dietary capsaicin or red pepper containing foods.
IV. Use of medication affecting GI function (prokinetics) or antisecretory medication (PPI) within 3 days prior to endoscopy.
V. Multisystem diseases (including severe cardiopulmonary disease, collagen diseases, coagulation disorders)
VI. Esophageal motility disorders
VII. Previous esophageal or gastric surgery
VIII. Use of anticoagulants or a history of coagulopathy
IX. Pregnancy
X. History of alcohol abuse or current excessive alcohol consumption (> 2 alcoholic beverages per day or > 14 alcoholic beverages per week).
XI. No allergies for capsaicin.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51999.068.15 |