A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

NCT ID: NCT05482256

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2023-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Esophageal String Test (EST)

Intervention Type 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.

Colgate

Intervention Type OTHER

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

High Resolution Esophageal Manometry (HREM)

Intervention Type 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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Colgate

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

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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EnteroTracker

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Benjamin L. Wright

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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22-003963

Identifier Type: -

Identifier Source: org_study_id

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