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

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 12-005914
  • NCT ID:

    NCT01733147
  • Sponsor Protocol Number:

    12-005914

About this study

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?

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Prasad Iyer, M.D.

Open for enrollment

Michele Johnson P.T.A.

(507)255-8692

johnson.michele@mayo.edu