A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05482256
• Other study ID #: 22-003963
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in IL-33 levels	Measured from esophageal string test eluates	Baseline, approximately 60 minutes after teeth brushing

External Links

•   Mayo Clinic Clinical Trials