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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsaicin | Active Comparator | 1,5 mg capsaicin in 30 minutes |
|
| Placebo | Placebo Comparator | 75 ml placebo (0,9 % saline) in 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Other | capsaicin 1,5 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Conchillo, MD, PhD | Maastricht University Medical Center (MUMC+) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Limburg | 6229 HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35351835 | Derived | Alleleyn AME, Keszthelyi D, Rinsma NF, Cseko K, Kajtar B, Helyes Z, Winkens B, Masclee AAM, Conchillo JM. The Potential Role for Impaired Mucosal Integrity in the Generation of Esophageal Pain Using Capsaicin in Humans: An Explorative Study. Clin Transl Gastroenterol. 2022 May 1;13(5):e00488. doi: 10.14309/ctg.0000000000000488. |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Other |
0,9% saline 75 ml |
|
| 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 |
| 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 |
| 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 |
| Symptom scores | The effect of capsaïcin infusion on symptoms in healthy volunteers. | Testday 1 and 2: during capsaicin and placebo infusion. |
| 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 |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |