A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis

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 Overview

• Status: Completed
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Diagnostic test: Esophageal String Test (EST); Other: Colgate; Diagnostic test: High Resolution Esophageal Manometry (HREM)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Benjamin Wright, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic - Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis; Cariostatic Agents; Inorganic Chemicals; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sodium Compounds; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Sodium Fluoride
• Other Study ID Numbers: 22-003963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No