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A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05482256
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
11
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Esophageal String Test (EST)
  • Other: Colgate
  • Diagnostic Test: High Resolution Esophageal Manometry (HREM)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Diagnostic Test: Esophageal 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.
Other Names:
  • EnteroTracker

    • Other: Colgate
    2 grams of toothpaste (pea sized amount) for 2 minutes

    Diagnostic Test: High 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

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. 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

    3. 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

    4. Change in IL-33 levels [Baseline, approximately 60 minutes after teeth brushing]

      Measured from esophageal string test eluates

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Benjamin Wright, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Benjamin L. Wright, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05482256
    Other Study ID Numbers:
    • 22-003963
    First Posted:
    Aug 1, 2022
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Esophagitis
    Eosinophilic Esophagitis
    Listerine
    Sodium Fluoride

    Study Results

    No Results Posted as of Aug 2, 2022