Obesity Clinical Trial
Official title:
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study
Verified date | December 2021 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 12, 2018 |
Est. primary completion date | September 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 ?3 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 |
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