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