Gastro-esophageal Reflux DiseaseNCT01867931
Epithelial Damage in GERD
An observational study of Gastro-esophageal Reflux Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to characterize and compare epithelial damage in patients with erosive esophagitis and non-erosive reflux disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastro-esophageal Reflux Disease
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Oct 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with EE and patients with NERD referred to the GI-outpatient clinic of the University Hospital Maastricht with an indication for diagnostic gastroscopy, as well healthy volunteers will be asked to participate in the study.
Who may be able to join
- Typical GERD-symptoms lasting for more than 6 months (recurrent episodes of heartburn or acid regurgitation)
- abnormal pH-parameters (pathological acid exposure and/or symptom association)
Who cannot join
- Age <18 years
- Previous esophageal or gastric surgery
- Severe esophageal motility disorder on manometry
- Histological evidence of Barrett's mucosa
- Severe co-morbidities (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorders and co-morbidity hindering a gastroscopic procedure)
- Use of anticoagulant or immunosuppressive drugs
Show all 9Show fewer
- Inability to stop medication that can influence the test results, like PPI, for at least 10 days before tests
- Excessive alcohol consumption (>20 units per week)
- Patients unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, 6229 HX
About this study
Official title: Characterisation of Esophageal Epithelial Damage in Patients With Non-erosive Reflux Disease (NERD) and Erosive Esophagitis (EE): Role of Epithelial Permeability
The purpose of this study is to characterize and compare epithelial damage in patients with erosive esophagitis and non-erosive reflux disease.
- Conditions
- Gastro-esophageal Reflux Disease
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Erosive Esophagitis | Not described | |
| Non-erosive Reflux Disease | Not described | |
| Heatlhy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelial integrity in tissue biopsies
Measured: 1 year
Secondary outcomes (2)
Immunohistochemical markers in tissue biopsies
Measured: 1 year
Histological changes in tissue biopsies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastro-esophageal Reflux DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J.M. Conchillo, MD PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867931
- Sponsor's protocol ID
- NL39721.068.12
- Status last verified
- Feb 2015
- First submitted
- 4 Apr 2013
- Last updated
- 20 Feb 2015
- Results posted
- No
Publications
Jovov B, Que J, Tobey NA, Djukic Z, Hogan BL, Orlando RC. Role of E-cadherin in the pathogenesis of gastroesophageal reflux disease. Am J Gastroenterol. 2011 Jun;106(6):1039-47. doi: 10.1038/ajg.2011.102. Epub 2011 Mar 29.
PubMed 21448147Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005 Mar;128(3):771-8. doi: 10.1053/j.gastro.2004.08.014.
PubMed 15765412
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Esophageal Epithelial Damage in Patients With Non-erosive Reflux Disease (NERD) and Erosive Esophagitis (EE): Role of Epithelial Permeability
- ClinicalTrials.gov ID
- NCT01867931
- Acronym / sponsor ID
- NL39721.068.12
- Conditions
- Gastro-esophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Jun 2013 (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.
The purpose of this study is to characterize and compare epithelial damage in patients with erosive esophagitis and non-erosive reflux disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erosive Esophagitis | – | – |
| Non-erosive Reflux Disease | – | – |
| Heatlhy volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with EE and patients with NERD referred to the GI-outpatient clinic of the University Hospital Maastricht with an indication for diagnostic gastroscopy, as well healthy volunteers will be asked to participate in the study.
Key inclusion criteria (2 listed)
- Typical GERD-symptoms lasting for more than 6 months (recurrent episodes of heartburn or acid regurgitation)
- abnormal pH-parameters (pathological acid exposure and/or symptom association)
Key exclusion criteria (9 listed)
- Age <18 years
- Previous esophageal or gastric surgery
- Severe esophageal motility disorder on manometry
- Histological evidence of Barrett's mucosa
- Severe co-morbidities (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorders and co-morbidity hindering a gastroscopic procedure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epithelial integrity in tissue biopsies
Time frame: 1 year
2 secondary outcomes
Immunohistochemical markers in tissue biopsies
Time frame: 1 year
Histological changes in tissue biopsies
Time frame: 1 year
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 20 Feb 2015.
- Background: PubMed 21448147Jovov B, Que J, Tobey NA, Djukic Z, Hogan BL, Orlando RC. Role of E-cadherin in the pathogenesis of gastroesophageal reflux disease. Am J Gastroenterol. 2011 Jun;106(6):1039-47. doi: 10.1038/ajg.2011.102. Epub 2011 Mar 29.
- Background: PubMed 15765412Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005 Mar;128(3):771-8. doi: 10.1053/j.gastro.2004.08.014.
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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.
J.M. Conchillo, MD PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro-esophageal Reflux Disease, 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 2 inclusion and 9 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 20 Feb 2015. 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. 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?
Epithelial integrity in tissue biopsies (time frame: 1 year). 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 NCT01867931, which also lists 2 linked publications.
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 20 Feb 2015.