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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

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