Eosinophilic Esophagitis
Conditions
Keywords
Mucosal Impedance, Eosinophilic Esophagitis, EoE
Brief summary
Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance? And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?
Interventions
DEVICEMucosal Impedance
A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.
PROCEDUREUpper Endoscopy
Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults ages 18-90 undergoing clinically indicated upper endoscopy * Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy * Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or Gastroesophageal reflux disease (GERD) with normal appearing esophageal mucosa.
Exclusion criteria
* Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy * Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome * Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal Mucosal Impedance (MI) | baseline to one year | An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Eosinophilic Esophagitis Subjects with an eosinophil count greater than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.
Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. | 10 |
| Inactive Eosinophilic Esophagitis Subjects with an eosinophil count less than 15 eosinophil per high-powered field (Eos/HPF) and do not have trouble swallowing during the clinical endoscopy
Mucosal Impedance: A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.
Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. | 10 |
| Control Group Subjects are those undergoing clinically indicated upper endoscopy for nonesophageal symptoms in whom a normal-appearing esophagus was found at the time of endoscopy
Upper Endoscopy: Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Active Eosinophilic Esophagitis | Total | Control Group | Inactive Eosinophilic Esophagitis |
|---|---|---|---|---|
| Age, Continuous | 41 years | 41 years | 37 years | 46 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 30 Participants | 10 Participants | 10 Participants |
| Region of Enrollment United States | 10 participants | 30 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 2 Participants | 10 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 20 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Esophageal Mucosal Impedance (MI)
An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction.
Time frame: baseline to one year
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Eosinophilic Esophagitis | Esophageal Mucosal Impedance (MI) | 2cm | 1457 Ohms |
| Active Eosinophilic Esophagitis | Esophageal Mucosal Impedance (MI) | 5cm | 1713 Ohms |
| Active Eosinophilic Esophagitis | Esophageal Mucosal Impedance (MI) | 10cm | 1731 Ohms |
| Active Eosinophilic Esophagitis | Esophageal Mucosal Impedance (MI) | 15cm | 1791 Ohms |
| Inactive Eosinophilic Esophagitis | Esophageal Mucosal Impedance (MI) | 15cm | 3378 Ohms |
| Inactive Eosinophilic Esophagitis | Esophageal Mucosal Impedance (MI) | 2cm | 3463 Ohms |
| Inactive Eosinophilic Esophagitis | Esophageal Mucosal Impedance (MI) | 10cm | 4500 Ohms |
| Inactive Eosinophilic Esophagitis | Esophageal Mucosal Impedance (MI) | 5cm | 5110 Ohms |
| Control Group | Esophageal Mucosal Impedance (MI) | 15cm | 6033 Ohms |
| Control Group | Esophageal Mucosal Impedance (MI) | 5cm | 4741 Ohms |
| Control Group | Esophageal Mucosal Impedance (MI) | 10cm | 5943 Ohms |
| Control Group | Esophageal Mucosal Impedance (MI) | 2cm | 4225 Ohms |