Non-erosive Reflux DiseaseCENERDDNCT02788591
Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection
A study testing Proton Pump Inhibitor (PPI) Therapy and Sucralfate in people with Non-erosive Reflux Disease and Gastroesophageal Reflux, run by LCMC Health at 2 sites in United States.
Trial summary
Primary Objective: Evaluate response to NERD treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. Secondary Objectives: To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-erosive Reflux Disease, Gastroesophageal Reflux
- What is being tested?
- Proton Pump Inhibitor (PPI) Therapy and Sucralfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals older than 18 years who score a 12 or greater on the Reflux Disease Questionnaire and have failed a four week trial of daily proton pump inhibitor.
- Subjects without gastroesophageal reflux disease (GERD) undergoing upper endomicroscopy for other indications will be recruited into study as controls.
Who cannot join
- Barrett's esophagus
- Use of twice daily proton pump inhibitor within 4 weeks of study entry
- Esophageal varices
- Coagulopathy (aspirin, NSAIDS and Plavix are allowed. Coumadin, Xarelto, heparin are not allowed.)
- Gastrointestinal cancer or mass
- Previous surgery involving the esophagus, stomach or duodenum
- Pregnancy
- Allergy to either sucralfate or proton pump inhibitors
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Touro Infirmary New Orleans
New Orleans, Louisiana, 70112
University Medical Center New Orleans
New Orleans, Louisiana, 70112
About this study
Official title: Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection (CENERDD)
Primary Objective:
Evaluate response to NERD treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings.
Secondary Objectives:
To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.
Quality of life at study entry and end of study. Compare two medications under study within each group as a subgroup analysis.
Read the detailed description
The purpose of this study is to evaluate response to non-erosive reflux disease (NERD) treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. The researchers will compare two different drug regimens for the NERD subjects to evaluate their effectiveness in reducing NERD-related symptoms. In addition, the researchers will be testing the function and effectiveness of the confocal endomicroscopy procedure to be used during the study. Researchers will be continuing to assess the status, symptoms, and any changes associated with the symptoms subjects are experiencing.
The confocal endomicroscopy procedure utilizes a powerful microscope that is used during an endoscopy. An endoscopy is a procedure that allows us to scope/view the inside of the esophagus and stomach using a camera in precise detail.
An endoscopy procedure and measurements of acid in the esophagus have been used to determine if the investigators think acid is causing the symptoms. Traditionally, acid blocking medications called proton pump inhibitors (PPIs such as Esomeprazole, Lansoprazole, Omeprazole, and Pantoprazole), or medications such as Sucralfate have been used to treat the symptoms of NERD.
The medical community believes that these symptoms are due to increased spaces between the cells that make up the esophagus. They can directly see those spaces using the confocal endomicroscopy.
Patients are asked to participate in this study if they are 18 years of age or older and have typical symptoms for patients diagnosed with NERD that have not responded to the first attempted medication.
- Being tested
- Proton Pump Inhibitor (PPI) Therapy, Sucralfate
- Medical subject headings
- Non-Erosive Reflux Disease, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Pump Inhibitor (PPI) TherapyDrug
Also called Omeprazole, Esomeprazole, Pantoprazole, Lansoprazole
Subject will take a proton pump inhibitor (PPI) of their choice (Omeprazole, Esomeprazole, Pantoprazole, or Lansoprazole) 2 times a day for 8 weeks.
SucralfateDrug
Also called Carafate
Subject will take Sucralfate 4 times a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Proton Pump Inhibitor (PPI) Therapy | Other | 2x daily Proton Pump Inhibitor (PPI) Therapy for 8 weeks Receives: Drug: Proton Pump Inhibitor (PPI) Therapy |
| Sucralfate | Other | 4x daily Sucralfate slurry, 1g, for 8 weeks Receives: Drug: Sucralfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate non erosive reflux disease (NERD) Symptoms.
Reflux Disease Questionnaire (RDQ)
Measured: 20 weeks
Secondary outcomes (3)
Evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.
A 3 minute video recording of microscopic images starting with the injection of the fluorescein will be captured during the time of endoscopy. The goal is also to see if the time to seeing fluorescein in the intracellular spaces correlates with a diagnosis of NERD. Time, measured in seconds, to first visualization of intrapapillary loops and intercellular gaps and fluorescein leak will be obtained and assess by trained endoscopists.
Measured: 20 weeks
Compare quality of life in patients with NERD.
Quality of life questionnaire (SF-36)
Measured: 20 weeks
Compare two medications within each NERD study groups as a subgroup analysis.
Categorical and binary demographics and outcomes will be assessed through a likelihood-ratio chi square test or a Fischer's exact test.Continuous outcomes, including time to fluorescein intracellular, will be assessed through a Student's t test or Wilcoxon rank sum, if the distribution of particular continuous variables is non-normal, tested through a Shapiro-Wilk statistic. Statistical significance will be determined at p values less than 0.05.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2021
- Study completionJun 2021
Why it stopped: lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- LCMC Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virendra Joshi, LCMC Health
- Investigators
- Virendra Joshi, MD, Principal investigator, LCMC Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788591
- Sponsor's protocol ID
- CENERDD
- Acronym
- CENERDD
- Status last verified
- Oct 2021
- First submitted
- 17 Mar 2016
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection (CENERDD)
- ClinicalTrials.gov ID
- NCT02788591
- Acronym / sponsor ID
- CENERDD / CENERDD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- LCMC HealthUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 2 Jun 2016 (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.
Primary Objective:
Evaluate response to NERD treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings.
Secondary Objectives:
To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.
Quality of life at study entry and end of study. Compare two medications under study within each group as a subgroup analysis.
Detailed description
The purpose of this study is to evaluate response to non-erosive reflux disease (NERD) treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. The researchers will compare two different drug regimens for the NERD subjects to evaluate their effectiveness in reducing NERD-related symptoms. In addition, the researchers will be testing the function and effectiveness of the confocal endomicroscopy procedure to be used during the study. Researchers will be continuing to assess the status, symptoms, and any changes associated with the symptoms subjects are experiencing.
The confocal endomicroscopy procedure utilizes a powerful microscope that is used during an endoscopy. An endoscopy is a procedure that allows us to scope/view the inside of the esophagus and stomach using a camera in precise detail.
An endoscopy procedure and measurements of acid in the esophagus have been used to determine if the investigators think acid is causing the symptoms. Traditionally, acid blocking medications called proton pump inhibitors (PPIs such as Esomeprazole, Lansoprazole, Omeprazole, and Pantoprazole), or medications such as Sucralfate have been used to treat the symptoms of NERD.
The medical community believes that these symptoms are due to increased spaces between the cells that make up the esophagus. They can directly see those spaces using the confocal endomicroscopy.
Patients are asked to participate in this study if they are 18 years of age or older and have typical symptoms for patients diagnosed with NERD that have not responded to the first attempted medication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Pump Inhibitor (PPI) Therapy | Other | Drug: Proton Pump Inhibitor (PPI) Therapy2x daily Proton Pump Inhibitor (PPI) Therapy for 8 weeks |
| Sucralfate | Other | Drug: Sucralfate4x daily Sucralfate slurry, 1g, for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals older than 18 years who score a 12 or greater on the Reflux Disease Questionnaire and have failed a four week trial of daily proton pump inhibitor.
- Subjects without gastroesophageal reflux disease (GERD) undergoing upper endomicroscopy for other indications will be recruited into study as controls.
Key exclusion criteria (8 listed)
- Barrett's esophagus
- Use of twice daily proton pump inhibitor within 4 weeks of study entry
- Esophageal varices
- Coagulopathy (aspirin, NSAIDS and Plavix are allowed. Coumadin, Xarelto, heparin are not allowed.)
- Gastrointestinal cancer or mass
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 |
|---|---|---|
| Proton Pump Inhibitor (PPI) TherapyAlso: Omeprazole, Esomeprazole, Pantoprazole, LansoprazoleSubject will take a proton pump inhibitor (PPI) of their choice (Omeprazole, Esomeprazole, Pantoprazole, or Lansoprazole) 2 times a day for 8 weeks. | Drug | Proton Pump Inhibitor (PPI) Therapy |
| SucralfateAlso: CarafateSubject will take Sucralfate 4 times a day for 8 weeks. | Drug | Sucralfate |
Primary outcome
Evaluate non erosive reflux disease (NERD) Symptoms.
Time frame: 20 weeks
Reflux Disease Questionnaire (RDQ)
3 secondary outcomes
Evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.
Time frame: 20 weeks
Compare quality of life in patients with NERD.
Time frame: 20 weeks
Compare two medications within each NERD study groups as a subgroup analysis.
Time frame: 20 weeks
Results and safety
The study was stopped early (reason given: lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Virendra Joshi, MD principal investigator
LCMC Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Pump Inhibitor (PPI) Therapy and Sucralfate in people with Non-erosive Reflux Disease and Gastroesophageal Reflux, run by LCMC Health at 2 sites 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 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: lack of accrual). 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?
Evaluate non erosive reflux disease (NERD) Symptoms. (time frame: 20 weeks). 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 9 Feb 2022.