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

Mayo Clinic60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Barrett's Esophagus Obesity

Interventions

Omega-3 polyunsaturated fatty acidsDRUG

3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.

PlaceboDRUG

3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria * Presence of BE defined as ≥ 1 cm of visible columnar mucosa in the distal esophagus with intestinal metaplasia on histology. * Absence of high grade dysplasia or EAC on baseline histology. * BMI \> 30 kg/m2 or waist circumference \> 102 cm in men, \> 88 cm in women. * Ability to give informed consent. Exclusion Criteria * Allergy to ω3 FFAs, fish or shellfish. * Presence of high grade dysplasia or cancer on histology. * Pregnant and or breastfeeding women * Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux. * Inability to give informed consent. * Currently taking Omega3 FFA as prescription. * Anti-coagulant therapy (Plavix, Warfarin, Coumadin) * AST or ALT level \> three times upper limit of normal at baseline * LDL \> 200 mg/dl at baseline. * INR \> 2

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Serum PGE2 Levels

Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw

Time frame: Baseline, 6 months

Change in Esophageal Tissue PGE2 Levels

Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection

Time frame: Baseline, 6 months

Secondary Outcomes

Change in Esophageal Macrophage Markers

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

Time frame: Baseline, 6 months

Data from ClinicalTrials.gov

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