Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Eosinophilic Esophagitis

Treatments: Other: Absorbable sugars

Study type: Interventional

Funder types: Other

Identifiers

NCT01641913

12-001344

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Absorbable sugars

Experimental group

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.

Treatment:

Other: Absorbable sugars