A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

Mayo Clinic12 enrolled

Overview

The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Eosinophilic Esophagitis

Interventions

Esophageal String Test (EST)DIAGNOSTIC_TEST

Non-invasive, FDA-registered sampling method to evaluate eosinophilic inflammation in the esophagus. The EST is performed by having an individual swallow a capsule attached to a string which captures secretions from the esophagus. The end of the string is taped to the cheek and the capsule is swallowed with water. After 1 hour, the EST will be removed, and the string will be processed for laboratory analysis.

ColgateOTHER

2 grams of toothpaste (pea sized amount) for 2 minutes

High Resolution Esophageal Manometry (HREM)DIAGNOSTIC_TEST

Thin flexible tube with sensors placed in the nose and swallowed for esophagus placement to conduct reading regarding the lining of the esophagus taken for approximately 10 minutes

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Normal, healthy volunteers. * Able to swallow pills. Exclusion Criteria: * Personal history of esophageal disease including but not limited to eosinophilic esophagitis, esophageal dysmotility, or GERD/reflux. * History of dysphagia (i.e., difficulty swallowing), chronic vomiting, chronic abdominal pain, unintentional weight loss. * Celiac disease, inflammatory bowel disease, irritable bowel syndrome, esophageal varices, chronic aspiration, connective tissue disorder, or known parasitic infection. * Gelatin allergy. * Use of a toothpaste containing SLS within 2 weeks of the study. * Pregnancy.

Locations (1)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Change in Mucosal impedance 15 minutes after exposure

Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology

Time frame: Baseline, 15 minutes after teeth brushing

Secondary Outcomes

Change in Mucosal impedance 30 minutes after exposure

Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology

Time frame: Baseline, 30 minutes after teeth brushing

Change in Mucosal impedance 45 minutes after exposure

Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology

Time frame: Baseline, 45 minutes after teeth brushing

Change in Mucosal impedance 60 minutes after exposure

Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology

Time frame: Baseline, 60 minutes after teeth brushing

Change in IL-33 levels

Measured from esophageal string test eluates

Time frame: Baseline, approximately 60 minutes after teeth brushing

Data from ClinicalTrials.gov

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