Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Gastrointestinal |
| Therapuetic Areas: | Endocrinology, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/6/2019 |
| Start Date: | November 2012 |
| End Date: | December 2019 |
Modulation of Esophageal Inflammation in Barrett&Apos;s Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot 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?
downregulate pro-neoplastic and pro-inflammatory pathways in the esophagus to
anti-inflammatory pathway?
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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-255-8692
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