Esophageal capsaïcin Infusion and Mucosal Integrity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-02-28

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Capsaicin

1,5 mg capsaicin in 30 minutes

Group Type ACTIVE_COMPARATOR

Capsaicin

Intervention Type OTHER

capsaicin 1,5 mg

Placebo

75 ml placebo (0,9 % saline) in 30 minutes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

0,9% saline 75 ml

Interventions

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Capsaicin

capsaicin 1,5 mg

Intervention Type OTHER

Placebo

0,9% saline 75 ml

Intervention Type OTHER

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes