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Completed

NCT Number: NCT01641913

Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients

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

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Absorbable sugars

Other

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 outcomes

  1. To assess patients gastrointestinal symptoms in patients with EoE by means of standard validated questionnaires

    Time frame: 30 days

    heartburn, trouble swallowing

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.

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Determination of Intestinal Permeability and Response to Treatment in Patients With Eosinophilic Esophagitis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2012
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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