Morphological Markers of Gastroesophageal Reflux Disease (GERD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Eric Chiou, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01921686
First received: August 9, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Eosinophilic Esophagitis
Gastroesophageal Reflux Disease
Other: Sample collection and Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • TEM analysis [ Time Frame: at time of sample collection ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • pH monitoring [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Immunoblotting [ Time Frame: At time of sample collection ] [ Designated as safety issue: Yes ]
    Evaluate the correlation between mean Dilated Intercellular Spaces diameter and injury to the Intercellular Junctional Complex (IJC) through immunoblotting-based assessment of cleaved versus intact e-cadherin.


Biospecimen Retention:   Samples Without DNA

Three esophageal biopsy samples


Estimated Enrollment: 45
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
Other: Sample collection and Questionnaire
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.
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.
Other: Sample collection and Questionnaire
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.
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).
Other: Sample collection and Questionnaire
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.

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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children between the ages of 8-18 years scheduled for endoscopy for clinical indication.

Criteria

Inclusion Criteria for GERD or EoE Subjects:

  • 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

Inclusion Criteria for Control Subjects:

  • 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

Exclusion Criteria for GERD or EoE Subjects:

  • History of Barrett's esophagus
  • Previous esophageal or gastric surgery
  • History of congenital defect/malformation of the esophagus
  • Diagnosis of Crohn disease

Exclusion Criteria for Control Subjects:

  • Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921686

Contacts
Contact: Brooke Bessard, B.S. 832-824-4267 bcbessar@texaschildrens.org
Contact: Supriya Parikh, MPH 832-824-3379 sxparikh@texaschildrens.org

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Brooke Bessard    832-824-4267    bcbessar@texaschildrens.org   
Principal Investigator: Eric H Chiou, MD         
Sub-Investigator: Bruno Chumpitazi, MD         
Sub-Investigator: Marcelo Vela, MD         
Sub-Investigator: M. John Hicks, MD         
Sub-Investigator: Hoda Malaty, MD         
Sub-Investigator: Caroyl Gilbert         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Eric H Chiou, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Eric Chiou, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01921686     History of Changes
Other Study ID Numbers: H-28604
Study First Received: August 9, 2013
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Eosinophil
Reflux
Esophagus
Food allergy
Trouble Swallowing
Pediatrics
Healthy Volunteers

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esophageal Motility Disorders
Deglutition Disorders
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014