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Completed

NCT Number: NCT01733147

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

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

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Body Weight Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Precancerous Conditions Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 polyunsaturated fatty acids

Drug

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)

Placebo

Drug

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.

Primary outcomes

  1. Change in Serum PGE2 Levels

    Time frame: Baseline, 6 months

    Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw

  2. Change in Esophageal Tissue PGE2 Levels

    Time frame: Baseline, 6 months

    Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection

Secondary outcomes

  1. Change in Esophageal Macrophage Markers

    Time frame: Baseline, 6 months

    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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2012
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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