Eosinophilic Esophagitis
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTEsophageal String Test (EST)
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.
OTHERColgate
2 grams of toothpaste (pea sized amount) for 2 minutes
DIAGNOSTIC_TESTHigh Resolution Esophageal Manometry (HREM)
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
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mucosal impedance 15 minutes after exposure | Baseline, 15 minutes after teeth brushing | Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mucosal impedance 30 minutes after exposure | Baseline, 30 minutes after teeth brushing | Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology |
| Change in Mucosal impedance 45 minutes after exposure | Baseline, 45 minutes after teeth brushing | Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology |
| Change in Mucosal impedance 60 minutes after exposure | Baseline, 60 minutes after teeth brushing | Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology |
| Change in IL-33 levels | Baseline, approximately 60 minutes after teeth brushing | Measured from esophageal string test eluates |
Countries
United States
Outcome results
None listed