A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

Not Applicable

Active, not recruiting

• Conditions: Eosinophilic Esophagitis
• Interventions: Diagnostic Test: Esophageal String Test (EST); Other: Colgate; Diagnostic Test: High Resolution Esophageal Manometry (HREM)

• Registration Number: NCT05482256
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2022-09-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toothpaste detergents with Eosinophilic Esophagitis Testing	Colgate	Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.
Toothpaste detergents with Eosinophilic Esophagitis Testing	Esophageal String Test (EST)	Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.
Toothpaste detergents with Eosinophilic Esophagitis Testing	High Resolution Esophageal Manometry (HREM)	Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
Change in IL-33 levels	Baseline, approximately 60 minutes after teeth brushing	Measured from esophageal string test eluates

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States