GERDNCT00624546
Effect of Antireflux Therapy on the Expression of Genes in Patients With GERD
An observational study of GERD and Gastroesophageal Reflux, run by University of Rochester at 1 site in United States.
Trial summary
Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux therapy are well known and extensively studied, little is known of the genetic events occurring in response to proton pump inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- GERD, Gastroesophageal Reflux
- What is being tested?
- Prevacid Solutabs and Antireflux surgery
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects: (a) 20 patients with GERD and (b) 20 non-GERD controls.
Who may be able to join
- For patients with GERD
- Patients referred for anti-reflux surgery
- On PPI therapy for at least 6 months
- Positive ambulatory pH monitoring (%time pH<4 > 4.7)
- Age greater than 18 years old.
- Both genders
Show all 11Show fewer
- For non-GERD controls
- Negative ambulatory pH monitoring OR
- Upper endoscopy performed for non-GERD symptoms.
- Age greater than 18 years old.
- Both genders
Who cannot join
- Prior foregut surgery
- Contra-indications for operation (poor clinical status, etc.)
- Contra-indications for endoscopy and biopsy (esophageal or gastric varices, therapeutic anticoagulation with Coumadin or Heparin, etc.)
- Unwillingness to participate in all of the follow-up studies
- Pregnancy
- Patients using medications that may interfere with PPIs pharmacokinetics (sucralfate, ketoconazole (Nizoral), ampicillin (Omnipen, Principen), digoxin (Lanoxin, Lanoxicaps), and iron (Feosol, Mol-Iron, Fergon, Femiron).
- Patients using medications that may interfere with gene expression (Immunosuppressants, Aspirin, NSAIDs, Corticosteroids).
- Patients with diseases that may interfere with gene expression (autoimmune diseases, diseases that course with immunosuppression).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Antireflux Therapy on the Expression of Genes Known to be Important in Inflammation, Metaplasia and Neoplasia in Patients With GERD
Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux therapy are well known and extensively studied, little is known of the genetic events occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory has shown, for example, that COX-2 expression is not only elevated in patients with gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery may normalize COX-2 gene expression. In contrast studies following ablation of dysplastic Barrett's epithelium have shown persistence of genetic changes associated with altered cellular function, despite the return of the histologic appearance to normal. Several key mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well characterized and shown to be important factors in the pathogenesis of esophageal injury. It is likely that successful antireflux therapy returns altered expression of these mediators toward normal although this hypothesis remains largely unexplored. The aim of this study is to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury and the response to antireflux therapy.
Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication) normalizes the expression of genes known to be involved in the pathogenesis of inflammation (esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).
Read the detailed description
Aims: To determine the effects of antireflux therapy (pump inhibitor and surgical fundoplication) on gene expression of:
- inflammation: IL-8, IFN-g, TNF-a.
- intestinal metaplasia: CDX-1/2, MUC2 and Sonic hedgehog.
- Neoplasia: Cox-2, VEGF, and EGFR.
- Conditions
- GERD, Gastroesophageal Reflux
- Being tested
- Prevacid Solutabs, Antireflux surgery
- Keywords
- GERD, gastroesophageal reflux, antireflux surgery, Barrett's, Esophagus, Esophagitis
- Medical subject headings
- Gastroesophageal Reflux, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevacid SolutabsDrug
BID Prevacid Solutabs
Antireflux surgeryProcedure or surgery
Lap Nissen
| Study group | Role | What they receive |
|---|---|---|
| 1 | gerd patients Receives: Drug: Prevacid Solutabs; Procedure: Antireflux surgery | |
| 2 | non gerd controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression
Measured: before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Expected recruitment numbers have not been achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Principal investigator, Jeffrey H Peters, University of Rochester
- Investigators
- Jeffrey H Peters, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624546
- Sponsor's protocol ID
- RSRB18199
- Other IDs
- rsrb18199
- Status last verified
- Oct 2015
- First submitted
- 28 Dec 2007
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antireflux Therapy on the Expression of Genes Known to be Important in Inflammation, Metaplasia and Neoplasia in Patients With GERD
- ClinicalTrials.gov ID
- NCT00624546
- Acronym / sponsor ID
- RSRB18199
- Conditions
- GERD, Gastroesophageal Reflux
- Keywords
- GERD, gastroesophageal reflux, antireflux surgery, Barrett's, Esophagus, Esophagitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Expected recruitment numbers have not been achieved.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Jan 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Feb 2008 (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.
Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux therapy are well known and extensively studied, little is known of the genetic events occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory has shown, for example, that COX-2 expression is not only elevated in patients with gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery may normalize COX-2 gene expression. In contrast studies following ablation of dysplastic Barrett's epithelium have shown persistence of genetic changes associated with altered cellular function, despite the return of the histologic appearance to normal. Several key mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well characterized and shown to be important factors in the pathogenesis of esophageal injury. It is likely that successful antireflux therapy returns altered expression of these mediators toward normal although this hypothesis remains largely unexplored. The aim of this study is to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury and the response to antireflux therapy.
Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication) normalizes the expression of genes known to be involved in the pathogenesis of inflammation (esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).
Detailed description
Aims: To determine the effects of antireflux therapy (pump inhibitor and surgical fundoplication) on gene expression of:
- inflammation: IL-8, IFN-g, TNF-a.
- intestinal metaplasia: CDX-1/2, MUC2 and Sonic hedgehog.
- Neoplasia: Cox-2, VEGF, and EGFR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Prevacid Solutabs, Procedure: Antireflux surgerygerd patients |
| 2 | – | –non gerd controls |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects: (a) 20 patients with GERD and (b) 20 non-GERD controls.
Key inclusion criteria (11 listed)
- For patients with GERD
- Patients referred for anti-reflux surgery
- On PPI therapy for at least 6 months
- Positive ambulatory pH monitoring (%time pH<4 > 4.7)
- Age greater than 18 years old.
Key exclusion criteria (8 listed)
- Prior foregut surgery
- Contra-indications for operation (poor clinical status, etc.)
- Contra-indications for endoscopy and biopsy (esophageal or gastric varices, therapeutic anticoagulation with Coumadin or Heparin, etc.)
- Unwillingness to participate in all of the follow-up studies
- Pregnancy
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 |
|---|---|---|
| Prevacid SolutabsBID Prevacid Solutabs | Drug | 1 |
| Antireflux surgeryLap Nissen | Procedure or surgery | 1 |
Primary outcome
gene expression
Time frame: before and after treatment
Results and safety
The study was stopped early (reason given: Expected recruitment numbers have not been achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
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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.
Jeffrey H Peters principal investigator
University of Rochester
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 GERD and Gastroesophageal Reflux, run by University of Rochester 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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 Oct 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 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 was stopped early (reason given: Expected recruitment numbers have not been achieved.). Results are not available in the source record.
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?
gene expression (time frame: before and after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2015.