Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients
Primary Purpose
Eosinophilic Esophagitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Absorbable sugars
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophilic Esophagitis
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Absorbable sugars
Arm Description
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.
Outcomes
Primary Outcome Measures
To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires
heartburn, trouble swallowing
Secondary Outcome Measures
To determine if patients with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01641913
Brief Title
Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients
Official Title
Determination of Intestinal Permeability and Response to Treatment in Patients With Eosinophilic Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophilic Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Absorbable sugars
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Absorbable sugars
Intervention Description
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 Measure Information:
Title
To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires
Description
heartburn, trouble swallowing
Time Frame
30 days
Secondary Outcome Measure Information:
Title
To determine if patients with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Katzka, MD
Organizational Affiliation
Mayo Clinic, Rochester, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients
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