A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

NCT05482256 | Completed

• 1 other identifier: 22-003963
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Toothpaste detergents with Eosinophilic Esophagitis Testing

EXPERIMENTAL

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); Other: Colgate; Diagnostic Test: High Resolution Esophageal Manometry (HREM)

Interventions

Esophageal String Test (EST) DIAGNOSTIC_TEST

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.

Also known as: EnteroTracker

Toothpaste detergents with Eosinophilic Esophagitis Testing

Colgate OTHER

2 grams of toothpaste (pea sized amount) for 2 minutes

Toothpaste detergents with Eosinophilic Esophagitis Testing

High Resolution Esophageal Manometry (HREM) DIAGNOSTIC_TEST

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

Toothpaste detergents with Eosinophilic Esophagitis Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal, healthy volunteers.
• Able to swallow pills.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic - Clinical Trials

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Sodium Fluoride

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Benjamin Wright, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: September 12, 2022
• Primary Completion: February 10, 2023
• Study Completion: February 10, 2023
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)