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

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

Official Title
-----------------
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study

Conditions
-----------------
Obesity, Barrett's Esophagus

Intervention / Treatment
-----------------
* Drug: Omega-3 polyunsaturated fatty acids
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* 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.<br>|
| Active Comparator: Omega-3 polyunsaturated fatty acids<br>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. | Drug: Omega-3 polyunsaturated fatty acids<br>* 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.<br>* Other names: Docosahexaenoic Acid (DHA)/Eicosapentaenoic Acid (EPA);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum PGE2 Levels | Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw | 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 | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Omega-3 fatty acid