Nitrates and IL-8 in Barrett's Esophagus

Barrett Esophagus Clinical Trial

Official title:

The Association Between Nitrates, Nitrosylated Proteins, and Interleukin-8 in Barrett's Esophagus and Esophageal Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04642690
• Other study ID #: 20-004618
• Status: Terminated
• Start date: September 24, 2020
• Est. completion date: December 9, 2022

Study information

• Verified date: December 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing worsening disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD).

Exclusion Criteria:

• Comorbid inflammatory medical condition.

• Use of antiinflammatory (aspirin and NSAIDs) or immunosuppressants over the past 1 week.

• Use of nitrate containing medication in the past 1 week.

• Consumption of nitrate rich foods in preceding 24 hours.

• Known allergy to meat or nitrates

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Esophageal Adenocarcinoma
• Esophageal Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nitrate Levels	Nitrate levels in serum, saliva and tissue in patients with normal squamous epithelium, erosive esophagitis, non-dysplastic BE (NDBE), and BE with high-grade dysplasia (HGD) or EAC	Baseline
Primary	Serum and Tissue Biomarkers	Levels of IL-8 in patients diagnosed BE dysplasia and EAC	Baseline
Secondary	Biomarkers and disease progression	Level of IL-8 in serum and tissue in patients with NDBE that progressed to BE	Baseline

External Links

•   Mayo Clinic Clinical Trials