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Esophageal capsaïcin Infusion and Mucosal Integrity

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ClinicalTrials.gov Identifier: NCT02603783
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
TRPV1 Protein, Human Capsaicin Electric Impedance Esophagus Intracellular Space Pain Measurement Microscopy, Electron Other: Capsaicin Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: "Effect of capsaïcin Infusion on Esophageal Mucosal Integrity - a Role for TRPV1-mediated Neuropeptides?"
Study Start Date : November 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Active Comparator: Capsaicin
1,5 mg capsaicin in 30 minutes
Other: Capsaicin
capsaicin 1,5 mg

Placebo Comparator: Placebo
75 ml placebo (0,9 % saline) in 30 minutes
Other: Placebo
0,9% saline 75 ml




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603783


Locations
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Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Jose Conchillo, MD, PhD Maastricht University Medical Center (MUMC+)
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02603783    
Other Study ID Numbers: METC 152005
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: October 2015
Additional relevant MeSH terms:
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Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs