Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients

Study Overview
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Brief Summary
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Do patient's with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids?

Detailed Description
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Eosinophilic esophagitis is an allergy mediated disease in which antigens exposed to the gastrointestinal tract trigger a combined immediate hypersensitivity. The investigators anticipate that patients with active eosinophilic esophagitis will have increased intestinal permeability on urine collection of sugars. The investigators are not sure whether these findings will be found in patients who have been successfully treated with topical esophageal steroids. Improvement in intestinal permeability would be perceived as indicating that esophageal disease drives the intestinal permeability. Lack of improvement would indicate that eosinophilic esophagitis is a more systemic disease in which increased small bowel permeability is a marker or perhaps important driver of the disease.

Official Title
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Determination of Intestinal Permeability and Response to Treatment in Patients With Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Other: Absorbable sugars


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between the ages of 18 and 80 with Eosinophilic Esophagitis diagnosed by compatible symptoms, endoscopic findings, histology and lack of response to proton pump inhibitors or negative pH study. Exclusion: Vulnerable populations, such as those with diminished mental acuity, will be excluded. Patients allergic to Lactulose Women who are pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorbable sugars<br>Lactulose (1,000 mg) and mannitol (200 mg). For the liquid formulation, these sugars will be administered in 250 ml of water. After oral ingestion of the sugars in liquid form, urine will be collected every 30 minutes for the first 2 hours. | Other: Absorbable sugars<br>* Lactulose (1,000 mg) and mannitol (200 mg). For the liquid formulation, these sugars will be administered in 250 ml of water. After oral ingestion of the sugars in liquid form, urine will be collected every 30 minutes for the first 2 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires | heartburn, trouble swallowing | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if patients with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids. |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophilic Esophagitis