TRPV1 Protein, HumanNCT02603783
Esophageal capsaïcin Infusion and Mucosal Integrity
A study testing Capsaicin in people with TRPV1 Protein, Human and Capsaicin, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- TRPV1 Protein, Human, Capsaicin, Electric Impedance
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: "Effect of capsaïcin Infusion on Esophageal Mucosal Integrity - a Role for TRPV1-mediated Neuropeptides?"
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
- Being tested
- Capsaicin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinOther
capsaicin 1,5 mg
PlaceboOther
0,9% saline 75 ml
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Active comparator | 1,5 mg capsaicin in 30 minutes Receives: Other: Capsaicin |
| Placebo | Placebo comparator | 75 ml placebo (0,9 % saline) in 30 minutes Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Secondary outcomes (6)
Mucosal integrity in the proximal non-exposed esophagus.
The effect of esophageal capsaïcin infusion on mucosal integrity as reflected by baseline impedance in the proximal non-exposed esophagus compared to control solution.
Measured: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Induction of dilated intercellular spaces (DIS)
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).
Measured: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
TRPV1 neuropeptide pathway
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.
Measured: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Immunohistochemical expression of TRPV1
The differences in immunohistochemical expression of TRPV1 during capsaïcin infusion or control solution in both the distal exposed and proximal non-exposed esophagus.
Measured: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Symptom scores
The effect of capsaïcin infusion on symptoms in healthy volunteers.
Measured: Testday 1 and 2: during capsaicin and placebo infusion.
TRPV1 neuropeptide pathway
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.
Measured: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TRPV1 Protein, HumanStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Conchillo, MD, PhD, Principal investigator, Maastricht University Medical Center (MUMC+)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603783
- Sponsor's protocol ID
- METC 152005
- Status last verified
- Oct 2015
- First submitted
- 30 Oct 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35351835
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of capsaïcin Infusion on Esophageal Mucosal Integrity - a Role for TRPV1-mediated Neuropeptides?"
- ClinicalTrials.gov ID
- NCT02603783
- Acronym / sponsor ID
- METC 152005
- Conditions
- TRPV1 Protein, Human, Capsaicin, Electric Impedance, Esophagus, Intracellular Space, Pain Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Active comparator | Other: Capsaicin1,5 mg capsaicin in 30 minutes |
| Placebo | Placebo comparator | Other: Placebo75 ml placebo (0,9 % saline) in 30 minutes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicincapsaicin 1,5 mg | Other | Capsaicin |
| Placebo0,9% saline 75 ml | Other | Placebo |
Primary outcome
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.
6 secondary outcomes
Mucosal integrity in the proximal non-exposed esophagus.
Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Induction of dilated intercellular spaces (DIS)
Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
TRPV1 neuropeptide pathway
Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Immunohistochemical expression of TRPV1
Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Symptom scores
Time frame: Testday 1 and 2: during capsaicin and placebo infusion.
TRPV1 neuropeptide pathway
Time frame: Testday 1 and 2: mucosal biopsies are taken during upper gastrointestinal endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 35351835Alleleyn 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Conchillo, MD, PhD principal investigator
Maastricht University Medical Center (MUMC+)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin in people with TRPV1 Protein, Human and Capsaicin, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02603783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.