Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients
Determination of Intestinal Permeability and Response to Treatment in Patients With Eosinophilic Esophagitis
1 other identifier
interventional
20
1 country
1
Brief Summary
Do patient's with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJune 24, 2014
June 1, 2014
1.4 years
July 10, 2012
June 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires
heartburn, trouble swallowing
30 days
Secondary Outcomes (1)
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
Study Arms (1)
Absorbable sugars
EXPERIMENTALLactulose (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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Vulnerable populations, such as those with diminished mental acuity, will be excluded.
- Patients allergic to Lactulose
- Women who are pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Katzka, MD
Mayo Clinic, Rochester, MN
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 10, 2012
First Posted
July 17, 2012
Study Start
August 1, 2012
Primary Completion
January 1, 2014
Study Completion
February 1, 2014
Last Updated
June 24, 2014
Record last verified: 2014-06