Esophageal capsaïcin Infusion and Mucosal Integrity

Pain Measurement Clinical Trial

Official title:

"Effect of capsaïcin Infusion on Esophageal Mucosal Integrity - a Role for TRPV1-mediated Neuropeptides?"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603783
• Other study ID #: METC 152005
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: May 16, 2017
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Capsaicin
• Electric Impedance
• Esophagus
• Intracellular Space
• Microscopy, Electron
• Pain Measurement
• TRPV1 Protein, Human

Intervention

Other:
• Capsaicin
capsaicin 1,5 mg
• Placebo
0,9% saline 75 ml

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mucosal integrity in the distal exposed esophagus during capsaicin infusion compared to control solution.	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.	Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Secondary	Mucosal integrity in the proximal non-exposed esophagus.	The effect of esophageal capsaïcin infusion on mucosal integrity as reflected by baseline impedance in the proximal non-exposed esophagus compared to control solution.	Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Secondary	Induction of dilated intercellular spaces (DIS)	The effect of esophageal capsaïcin infusion on the induction of dilated intercellular spaces (DIS) in the distal exposed and proximal non-exposed esophagus as measured with transmission electron microscopy (TEM).	Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Secondary	TRPV1 neuropeptide pathway	The differences in the TRPV1 neuropeptide pathway (substance P) by radioimmunoassay (RIA) during capsaïcin infusion or control solution in both the distal exposed and proximal non-exposed esophagus.	Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Secondary	Immunohistochemical expression of TRPV1	The differences in immunohistochemical expression of TRPV1 during capsaïcin infusion or control solution in both the distal exposed and proximal non-exposed esophagus.	Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Secondary	Symptom scores	The effect of capsaïcin infusion on symptoms in healthy volunteers.	Testday 1 and 2: during capsaicin and placebo infusion.
Secondary	TRPV1 neuropeptide pathway	The differences in the TRPV1 neuropeptide pathway (CGRP) by radioimmunoassay (RIA) during capsaïcin infusion or control solution in both the distal exposed and proximal non-exposed esophagus.	Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy