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Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids | Clinical Trials | Clareo Health

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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

NCT01733147•Mayo Clinic

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

November 1, 2012

Primary Completion Date

September 12, 2018

Completion Date

September 12, 2018

Last Updated

January 11, 2022

Enrollment

ACTUAL participants

Conditions

Barrett's EsophagusObesity

Interventions

Omega-3 polyunsaturated fatty acids

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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