Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids

Phase 4

Completed

• Conditions: Barrett's Esophagus; Obesity
• Interventions: Drug: Placebo; Drug: Omega-3 polyunsaturated fatty acids

• Registration Number: NCT01733147
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-26
• Primary Completion: 2018-09-12
• Study Completion: 2018-09-12
• Status Verified: 2021-12
• Results First Submitted: 2021-12-13
• Results First Submitted QC: 2021-12-13
• Last Update Submitted: 2021-12-13
• Results First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.
Omega-3 polyunsaturated fatty acids	Omega-3 polyunsaturated fatty acids	Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.

Primary Outcome Measures

Name	Time	Method
Change in Serum PGE2 Levels	Baseline, 6 months	Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw
Change in Esophageal Tissue PGE2 Levels	Baseline, 6 months	Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection

Secondary Outcome Measures

Name	Time	Method
Change in Esophageal Macrophage Markers	Baseline, 6 months	Percent change from baseline to 6 months in esophageal macrophage markers MCP-1 (Pro-inflammatory, M1 marker), CD 206 (Anti-inflammatory, M2 marker), and IL-10 (Anti-inflammatory, M2 marker) obtained from endoscopic esophageal tissue collection

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States