Esophageal capsaïcin Infusion and Mucosal Integrity

NCT02603783 | Completed DMC

• 1 other identifier: METC 152005
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Mucosal integrity in the proximal non-exposed esophagus.

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

• Induction of dilated intercellular spaces (DIS)

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

• TRPV1 neuropeptide pathway

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

• Immunohistochemical expression of TRPV1

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

• Symptom scores

  Testday 1 and 2: during capsaicin and placebo infusion.

Study Arms (2)

Capsaicin

ACTIVE COMPARATOR

1,5 mg capsaicin in 30 minutes

Other: Capsaicin

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Capsaicin OTHER

capsaicin 1,5 mg

Capsaicin

Placebo OTHER

0,9% saline 75 ml

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 35351835 DERIVED

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Jose Conchillo, MD, PhD

  Maastricht University Medical Center (MUMC+)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 13, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 17, 2017

Record last verified: 2015-10

Locations

NL (1)