Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients

Phase 1

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Other: Absorbable sugars

• Registration Number: NCT01641913
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Study Start: 2012-08
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Absorbable sugars	Absorbable sugars	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.

Primary Outcome Measures

Name	Time	Method
To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires	30 days	heartburn, trouble swallowing

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States