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Completed

NCT Number: NCT05482256

A Study 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: EnteroTracker

Colgate

Other

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

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

Primary outcomes

  1. 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

  1. Change in Mucosal impedance 30 minutes after exposure

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, approximately 60 minutes after teeth brushing

    Measured from esophageal string test eluates

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2022
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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