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Esophageal capsaïcin Infusion and Mucosal Integrity

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

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

Treatments

Other: Capsaicin
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02603783
METC 152005

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

13 participants in 2 patient groups, including a placebo group

Capsaicin
Active Comparator group
Description:
1,5 mg capsaicin in 30 minutes
Treatment:
Other: Capsaicin
Placebo
Placebo Comparator group
Description:
75 ml placebo (0,9 % saline) in 30 minutes
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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