Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 20
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.
- ...
- 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
- AST or ALT level > three times upper limit of normal at baseline
- Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux.
- Currently taking Omega3 FFA as prescription.
- ...
- AST or ALT level > three times upper limit of normal at baseline
- Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux.
- Currently taking Omega3 FFA as prescription.
- Presence of high grade dysplasia or cancer on histology.
- Inability to give informed consent.
- LDL > 200 mg/dl at baseline.
- Anti-coagulant therapy (Plavix, Warfarin, Coumadin)
- Pregnant and or breastfeeding women
- Allergy to ω3 FFAs, fish or shellfish.
- INR > 2
Summary
- Conditions
- Barrett's Esophagus
- Obesity
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
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.
- ...
- 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
- AST or ALT level > three times upper limit of normal at baseline
- Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux.
- Currently taking Omega3 FFA as prescription.
- ...
- AST or ALT level > three times upper limit of normal at baseline
- Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux.
- Currently taking Omega3 FFA as prescription.
- Presence of high grade dysplasia or cancer on histology.
- Inability to give informed consent.
- LDL > 200 mg/dl at baseline.
- Anti-coagulant therapy (Plavix, Warfarin, Coumadin)
- Pregnant and or breastfeeding women
- Allergy to ω3 FFAs, fish or shellfish.
- INR > 2
Tracking Information
- NCT #
- NCT01733147
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Prasad Iyer, MD Mayo Clinic
- Prasad Iyer, MD Mayo Clinic
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