Eosinophilic EsophagitisNCT01921686
Morphological Markers of Gastroesophageal Reflux Disease (GERD)
An observational study of Eosinophilic Esophagitis and Gastroesophageal Reflux Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis, Gastroesophageal Reflux Disease
- What is being tested?
- Sample collection and Questionnaire
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2026
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children between the ages of 8-18 years scheduled for endoscopy for clinical indication.
Who may be able to join
- Children between the ages of 8-18 years
- Suspected diagnosis of GERD or EoE based on symptom criteria
- Able to tolerate upper endoscopy examination with biopsies
- Children between the ages of 8-18
- Scheduled for EGD for clinical indications
- No history of esophageal disease of esophageal symptoms
- Able to tolerate upper endoscopy examination with biopsies
Who cannot join
- History of Barrett's esophagus
- Previous esophageal or gastric surgery
- History of congenital defect/malformation of the esophagus
- Diagnosis of Crohn disease
- Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children
The purpose of this project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid reflux.
Read the detailed description
This will be a prospective case control study. Children between the ages of 8 and 18 with suspected gastroesophageal reflux disease (GERD) or eosinophilic esophagitis (EoE) based on symptom criteria and who have been scheduled for esophagogastroduodenoscopy (EGD) by their primary gastroenterologist will be recruited.
Children who do not have any history of esophageal disease or esophageal symptoms and are scheduled for EGD for other clinical indications (e.g. rule out celiac disease) by their primary gastroenterologist will be recruited and act as controls. Control subjects will also be given the opportunity to undergo esophageal MII-pH monitoring as part of their medical evaluation, but will not be excluded from analysis should they opt out of this part of the study.
For all subjects, in addition to endoscopic evaluation, biopsies of the distal esophagus will be obtained for routine light microscopy (standard histology sample) as well as Transmission Electron Microscopy (TEM) analysis to determine the presence and magnitude of dilated intercellular spaces (DIS), and immunoblotting for e-cadherin cleavage
- Being tested
- Sample collection and Questionnaire
- Keywords
- Eosinophil, Reflux, Esophagus, Food allergy, Trouble Swallowing, Pediatrics, Healthy Volunteers
- Medical subject headings
- Eosinophilic Esophagitis, Gastroesophageal Reflux, Food Hypersensitivity, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collection and QuestionnaireOther
This is an observational biospecimen collection and questionnaire study. The subjects will be asked to complete a symptom questionnaire at screening visit. In addition, 3 esophageal biopsy samples will be taken to conduct laboratory analyses.
| Study group | Role | What they receive |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) | History of troublesome symptoms (e.g. heartburn, chest pain, acid regurgitation) secondary to reflux of gastric contents at least three times per week
AND, At least one of the following:
* Mucosal breaks on endoscopy (at least Grade-A esophagitis based on Los Angeles classification)
* Abnormal pH index (pH less than 4 for greater than 6% of study)
* Abnormal MII-pH (greater than 73 episodes of total reflux per 24 hours) Receives: Other: Sample collection and Questionnaire | |
| Eosinophilic Esophagitis (EoE) | * History of troublesome esophageal symptoms (e.g. dysphagia, food impaction, vomiting, upper abdominal or chest pain)
* Greater than or equal to 15 eosinophils in at least one high powered field (HPF) from distal OR proximal esophageal biopsy
* Lack of histological response to 6-8 weeks of high dose Proton Pump Inhibitor (PPI) OR negative pH probe (pH less than 4 for less than 6% of study). Subjects with greater than 15 eosinophils/HPF and abnormal pH results may have an overlap syndrome and will be excluded from the primary analysis. Receives: Other: Sample collection and Questionnaire | |
| Control | Patients with no history of troublesome esophageal symptoms or esophageal disease AND normal esophagoscopy (for example, patients undergoing evaluation for chronic abdominal pain, inflammatory bowel disease, celiac disease). Receives: Other: Sample collection and Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEM analysis
Using transmission electron microscopy (TEM), compare mean Dilated Intercellular Space diameter of esophageal epithelium in children with GERD to children with Eosinophilic Esophagitis and normal controls.
Measured: at time of sample collection
Secondary outcomes (1)
pH monitoring
Evaluate the correlation between mean Dilated Intercellular Spaces diameter and quantitative reflux parameters determined by 24-hour esophageal multichannel intraluminal impedance-pH (MII-pH) monitoring
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionDec 2026 (estimated)
Why it stopped: Study objectives were not met and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Chiou, Baylor College of Medicine
- Investigators
- Eric H Chiou, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921686
- Sponsor's protocol ID
- H-28604
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2013
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children
- ClinicalTrials.gov ID
- NCT01921686
- Acronym / sponsor ID
- H-28604
- Keywords
- Eosinophil, Reflux, Esophagus, Food allergy, Trouble Swallowing, Pediatrics, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study objectives were not met and lack of funding
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Aug 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 project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid reflux.
Detailed description
This will be a prospective case control study. Children between the ages of 8 and 18 with suspected gastroesophageal reflux disease (GERD) or eosinophilic esophagitis (EoE) based on symptom criteria and who have been scheduled for esophagogastroduodenoscopy (EGD) by their primary gastroenterologist will be recruited.
Children who do not have any history of esophageal disease or esophageal symptoms and are scheduled for EGD for other clinical indications (e.g. rule out celiac disease) by their primary gastroenterologist will be recruited and act as controls. Control subjects will also be given the opportunity to undergo esophageal MII-pH monitoring as part of their medical evaluation, but will not be excluded from analysis should they opt out of this part of the study.
For all subjects, in addition to endoscopic evaluation, biopsies of the distal esophagus will be obtained for routine light microscopy (standard histology sample) as well as Transmission Electron Microscopy (TEM) analysis to determine the presence and magnitude of dilated intercellular spaces (DIS), and immunoblotting for e-cadherin cleavage
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) | – | Other: Sample collection and QuestionnaireHistory of troublesome symptoms (e.g. heartburn, chest pain, acid regurgitation) secondary to reflux of gastric contents at least three times per week AND, At least one of the following: * Mucosal breaks on endoscopy (at least Grade-A esophagitis based on Los Angeles classification) * Abnormal pH index (pH less than 4 for greater than 6% of study) * Abnormal MII-pH (greater than 73 episodes of total reflux per 24 hours) |
| Eosinophilic Esophagitis (EoE) | – | Other: Sample collection and Questionnaire* History of troublesome esophageal symptoms (e.g. dysphagia, food impaction, vomiting, upper abdominal or chest pain) * Greater than or equal to 15 eosinophils in at least one high powered field (HPF) from distal OR proximal esophageal biopsy * Lack of histological response to 6-8 weeks of high dose Proton Pump Inhibitor (PPI) OR negative pH probe (pH less than 4 for less than 6% of study). Subjects with greater than 15 eosinophils/HPF and abnormal pH results may have an overlap syndrome and will be excluded from the primary analysis. |
| Control | – | Other: Sample collection and QuestionnairePatients with no history of troublesome esophageal symptoms or esophageal disease AND normal esophagoscopy (for example, patients undergoing evaluation for chronic abdominal pain, inflammatory bowel disease, celiac disease). |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children between the ages of 8-18 years scheduled for endoscopy for clinical indication.
Key inclusion criteria (7 listed)
- Children between the ages of 8-18 years
- Suspected diagnosis of GERD or EoE based on symptom criteria
- Able to tolerate upper endoscopy examination with biopsies
- Children between the ages of 8-18
- Scheduled for EGD for clinical indications
Key exclusion criteria (5 listed)
- History of Barrett's esophagus
- Previous esophageal or gastric surgery
- History of congenital defect/malformation of the esophagus
- Diagnosis of Crohn disease
- Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing).
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 |
|---|---|---|
| Sample collection and QuestionnaireThis is an observational biospecimen collection and questionnaire study. The subjects will be asked to complete a symptom questionnaire at screening visit. In addition, 3 esophageal biopsy samples will be taken to conduct laboratory analyses. | Other | Control, Eosinophilic Esophagitis (EoE), Gastroesophageal Reflux Disease (GERD) |
Primary outcome
TEM analysis
Time frame: at time of sample collection
Using transmission electron microscopy (TEM), compare mean Dilated Intercellular Space diameter of esophageal epithelium in children with GERD to children with Eosinophilic Esophagitis and normal controls.
1 secondary outcome
pH monitoring
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Physician ProfileLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Eric H Chiou, MD principal investigator
Baylor College of Medicine
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 Eosinophilic Esophagitis and Gastroesophageal Reflux Disease, run by Baylor College of Medicine 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 7 inclusion and 5 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: paused, as of the sponsor's last update on 17 Aug 2026. 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?
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?
TEM analysis (time frame: at time of sample collection). 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 17 Aug 2026.