The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Mucosal impedance 15 minutes after exposure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Toothpaste detergents with Eosinophilic Esophagitis Testing
Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.
Intervention: Esophageal String Test (EST) (Diagnostic Test)
Toothpaste detergents with Eosinophilic Esophagitis Testing
Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.
Intervention: Colgate (Other)
Toothpaste detergents with Eosinophilic Esophagitis Testing
Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.
Intervention: High Resolution Esophageal Manometry (HREM) (Diagnostic Test)
Outcomes
Primary Outcomes
Change in Mucosal impedance 15 minutes after exposure
Time Frame: Baseline, 15 minutes after teeth brushing
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Secondary Outcomes
- Change in Mucosal impedance 30 minutes after exposure(Baseline, 30 minutes after teeth brushing)
- Change in Mucosal impedance 45 minutes after exposure(Baseline, 45 minutes after teeth brushing)
- Change in Mucosal impedance 60 minutes after exposure(Baseline, 60 minutes after teeth brushing)
- Change in IL-33 levels(Baseline, approximately 60 minutes after teeth brushing)
Investigators
Benjamin L. Wright
Principal Investigator
Mayo Clinic