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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Obesity; Barrett's Esophagus

Treatments: Drug: Omega-3 polyunsaturated fatty acids; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01733147

12-005914

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Omega-3 polyunsaturated fatty acids

Active Comparator group

Description:

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.

Treatment:

Drug: Omega-3 polyunsaturated fatty acids