Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01641913
First received: July 10, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Eosinophilic Esophagitis
Other: Absorbable sugars
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determination of Intestinal Permeability and Response to Treatment in Patients With Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2012
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01641913

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Katzka, MD Mayo Clinic Rochester, MN
  More Information

No publications provided

Responsible Party: David A. Katzka, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01641913     History of Changes
Other Study ID Numbers: 12-001344
Study First Received: July 10, 2012
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Eosinophilic Esophagitis

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014