Back to resultsA Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis
Primary Purpose
Eosinophilic Esophagitis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophageal String Test (EST)
Colgate
High Resolution Esophageal Manometry (HREM)
Sponsored by
About this trial
This is an interventional health services research trial for Eosinophilic Esophagitis
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Toothpaste detergents with Eosinophilic Esophagitis Testing
Arm Description
Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.
Outcomes
Primary Outcome Measures
Change in Mucosal impedance 15 minutes after exposure
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Secondary Outcome Measures
Change in Mucosal impedance 30 minutes after exposure
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Change in Mucosal impedance 45 minutes after exposure
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Change in Mucosal impedance 60 minutes after exposure
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Change in IL-33 levels
Measured from esophageal string test eluates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05482256
Brief Title
A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis
Official Title
The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toothpaste detergents with Eosinophilic Esophagitis Testing
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
Esophageal String Test (EST)
Other Intervention Name(s)
EnteroTracker
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Colgate
Intervention Description
2 grams of toothpaste (pea sized amount) for 2 minutes
Intervention Type
Diagnostic Test
Intervention Name(s)
High Resolution Esophageal Manometry (HREM)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Mucosal impedance 15 minutes after exposure
Description
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Time Frame
Baseline, 15 minutes after teeth brushing
Secondary Outcome Measure Information:
Title
Change in Mucosal impedance 30 minutes after exposure
Description
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Time Frame
Baseline, 30 minutes after teeth brushing
Title
Change in Mucosal impedance 45 minutes after exposure
Description
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Time Frame
Baseline, 45 minutes after teeth brushing
Title
Change in Mucosal impedance 60 minutes after exposure
Description
Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology
Time Frame
Baseline, 60 minutes after teeth brushing
Title
Change in IL-33 levels
Description
Measured from esophageal string test eluates
Time Frame
Baseline, approximately 60 minutes after teeth brushing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Wright, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis
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