Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients

• ClinicalTrials.gov Identifier: NCT01641913
• Recruitment Status: Completed
• First Posted: July 17, 2012
• Last Update Posted: June 24, 2014
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): David A. Katzka, Mayo Clinic

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?

Condition or disease	Intervention/treatment	Phase
Eosinophilic Esophagitis	Other: Absorbable sugars	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Determination of Intestinal Permeability and Response to Treatment in Patients With Eosinophilic Esophagitis
• Study Start Date: August 2012
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: February 2014

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires [ Time Frame: 30 days ]
   heartburn, trouble swallowing

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: David A. Katzka, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01641913
• Other Study ID Numbers: 12-001344
• First Posted: July 17, 2012
• Last Update Posted: June 24, 2014
• Last Verified: June 2014

Keywords provided by David A. Katzka, 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