Modulation of Esophageal Inflammation in Barrett&Apos;s Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Will oral supplementation with Omega 3 free fatty acids in obese Barrett's esophagus subjects downregulate pro-neoplastic and pro-inflammatory pathways in the esophagus to anti-inflammatory pathway?

Who is eligible to participate?

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 or as supplement. - 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

Last updated:

5/29/2014

NCT ID:

NCT01733147

IRB Number:

12-005914