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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Barrett's Esophagus
• Intervention / Treatment: Drug: Placebo; Drug: Omega-3 polyunsaturated fatty acids

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; 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.
Active Comparator: Omega-3 polyunsaturated fatty acids; 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; 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.; 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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Prasad Iyer, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 12, 2018
• Study Completion (Actual): September 12, 2018

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 26, 2012

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Omega-3 fatty acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Precancerous Conditions; Inflammation; Barrett Esophagus; Esophagitis
• Other Study ID Numbers: 12-005914

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No