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NCT Number: NCT02603783

Esophageal capsaïcin Infusion and Mucosal Integrity

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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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Capsaicin

Other

capsaicin 1,5 mg

Placebo

Other

0,9% saline 75 ml

Primary outcomes

  1. Changes in mucosal integrity in the distal exposed esophagus during capsaicin infusion compared to control solution.

    Time frame: 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.

Secondary outcomes

  1. Mucosal integrity in the proximal non-exposed esophagus.

    Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy

    The effect of esophageal capsaïcin infusion on mucosal integrity as reflected by baseline impedance in the proximal non-exposed esophagus compared to control solution.

  2. Induction of dilated intercellular spaces (DIS)

    Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy

    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).

  3. TRPV1 neuropeptide pathway

    Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy

    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.

  4. Immunohistochemical expression of TRPV1

    Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy

    The differences in immunohistochemical expression of TRPV1 during capsaïcin infusion or control solution in both the distal exposed and proximal non-exposed esophagus.

  5. Symptom scores

    Time frame: Testday 1 and 2: during capsaicin and placebo infusion.

    The effect of capsaïcin infusion on symptoms in healthy volunteers.

  6. TRPV1 neuropeptide pathway

    Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy

    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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2015
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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