EsophagitisNCT01733810
The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
A study testing Cessation of Acid Suppressing Medications in people with Esophagitis and Reflux Esophagitis, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagitis, Reflux Esophagitis, Gastroesophageal Reflux Disease
- What is being tested?
- Cessation of Acid Suppressing Medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2013to 31 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- U.S Veteran
- History of Los Angeles Grade C erosive esophagitis
Who cannot join
- Inability to provide informed consent
- Esophageal varices
- Warfarin use
- Coagulopathy that precludes safe biopsy of the esophagus
- Comorbidity that precludes safe participation in the study
- Allergy to fluorescein sodium
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis.
Read the detailed description
Reflux esophagitis is thought to be caused by gastric acid that refluxes into the esophagus, causing injury. Newer data suggest that reflux of gastric juice into the esophagus stimulates HIF-2a, which increases production of inflammatory cytokines. These cytokines are thought to lead to reflux esophagitis. The investigators plan to study the relationship of HIF-2a to inflammatory cytokines in patients with known gastroesophageal reflux disease and reflux esophagitis.
- Being tested
- Cessation of Acid Suppressing Medications
- Keywords
- Esophagitis, Reflux esophagitis, Gastroesophageal reflux disease, Acid, Inflammation, Esophagus, Cytokines, Esophageal squamous cell, Reflux, Squamous epithelium
- Medical subject headings
- Esophagitis, Esophagitis, Peptic, Gastroesophageal Reflux, Heartburn, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation of Acid Suppressing MedicationsOther
Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.
| Study group | Role | What they receive |
|---|---|---|
| Reflux Patients | Experimental | Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications. Receives: Other: Cessation of Acid Suppressing Medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in esophageal inflammation from baseline to 14 days
inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days
Measured: day 0 and day 14
Secondary outcomes (1)
change in HIF-2a levels from baseline to 14 days
Amount of HIF-2a present will be measured at baseline and at 14 days
Measured: day 0 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start1 Feb 2013
- Primary completion31 Jul 2015
- Study completion31 Jul 2019
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 EsophagitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Stuart Spechler, Dallas VA Medical Center
- Investigators
- Stuart J Spechler, MD, Principal investigator, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733810
- Sponsor's protocol ID
- 2R01DK063621-11
- Other IDs
- R01DK063621
- Status last verified
- Feb 2020
- First submitted
- 16 Nov 2012
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Huo X, Agoston AT, Dunbar KB, Cipher DJ, Zhang X, Yu C, Cheng E, Zhang Q, Pham TH, Tambar UK, Bruick RK, Wang DH, Odze RD, Spechler SJ, Souza RF. Hypoxia-inducible factor-2alpha plays a role in mediating oesophagitis in GORD. Gut. 2017 Sep;66(9):1542-1554. doi: 10.1136/gutjnl-2016-312595. Epub 2016 Sep 30.
PubMed 27694141Dunbar KB, Agoston AT, Odze RD, Huo X, Pham TH, Cipher DJ, Castell DO, Genta RM, Souza RF, Spechler SJ. Association of Acute Gastroesophageal Reflux Disease With Esophageal Histologic Changes. JAMA. 2016 May 17;315(19):2104-12. doi: 10.1001/jama.2016.5657.
PubMed 27187303
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT01733810
- Acronym / sponsor ID
- 2R01DK063621-11
- Keywords
- Esophagitis, Reflux esophagitis, Gastroesophageal reflux disease, Acid, Inflammation, Esophagus, Cytokines, Esophageal squamous cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 27 Nov 2012 (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 determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis.
Detailed description
Reflux esophagitis is thought to be caused by gastric acid that refluxes into the esophagus, causing injury. Newer data suggest that reflux of gastric juice into the esophagus stimulates HIF-2a, which increases production of inflammatory cytokines. These cytokines are thought to lead to reflux esophagitis. The investigators plan to study the relationship of HIF-2a to inflammatory cytokines in patients with known gastroesophageal reflux disease and reflux esophagitis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reflux Patients | Experimental | Other: Cessation of Acid Suppressing MedicationsPatients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- U.S Veteran
- History of Los Angeles Grade C erosive esophagitis
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Esophageal varices
- Warfarin use
- Coagulopathy that precludes safe biopsy of the esophagus
- Comorbidity that precludes safe participation in the study
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 |
|---|---|---|
| Cessation of Acid Suppressing MedicationsAcid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications. | Other | Reflux Patients |
Primary outcome
change in esophageal inflammation from baseline to 14 days
Time frame: day 0 and day 14
inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days
1 secondary outcome
change in HIF-2a levels from baseline to 14 days
Time frame: day 0 and day 14
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 5 Feb 2020.
- Derived from this study: PubMed 27694141Huo X, Agoston AT, Dunbar KB, Cipher DJ, Zhang X, Yu C, Cheng E, Zhang Q, Pham TH, Tambar UK, Bruick RK, Wang DH, Odze RD, Spechler SJ, Souza RF. Hypoxia-inducible factor-2alpha plays a role in mediating oesophagitis in GORD. Gut. 2017 Sep;66(9):1542-1554. doi: 10.1136/gutjnl-2016-312595. Epub 2016 Sep 30.
- Derived from this study: PubMed 27187303Dunbar KB, Agoston AT, Odze RD, Huo X, Pham TH, Cipher DJ, Castell DO, Genta RM, Souza RF, Spechler SJ. Association of Acute Gastroesophageal Reflux Disease With Esophageal Histologic Changes. JAMA. 2016 May 17;315(19):2104-12. doi: 10.1001/jama.2016.5657.
Related trials for Esophagitis
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
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.
Stuart J Spechler, MD principal investigator
Dallas VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cessation of Acid Suppressing Medications in people with Esophagitis and Reflux Esophagitis, run by Dallas VA Medical Center at 1 site in United States.
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 7 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 5 Feb 2020. 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 United States. 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?
change in esophageal inflammation from baseline to 14 days (time frame: day 0 and day 14). 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 NCT01733810, 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 5 Feb 2020.