A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Diagnostic Test: Esophageal String Test (EST)
* Other: Colgate
* Diagnostic Test: High Resolution Esophageal Manometry (HREM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toothpaste detergents with Eosinophilic Esophagitis Testing<br>Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste. | Diagnostic Test: Esophageal String Test (EST)<br>* 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.<br>* Other names: EnteroTracker;Other: Colgate<br>* 2 grams of toothpaste (pea sized amount) for 2 minutes<br>Diagnostic Test: High Resolution Esophageal Manometry (HREM)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mucosal impedance 15 minutes after exposure | Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology | Baseline, 15 minutes after teeth brushing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mucosal impedance 30 minutes after exposure | Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology | 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 | 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 | Baseline, 60 minutes after teeth brushing | 
| Change in IL-33 levels | Measured from esophageal string test eluates | Baseline, approximately 60 minutes after teeth brushing |