Phase 4
N=60
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
Barrett's Esophagus · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01733147 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Change in Serum PGE2 Levels — 4.44; -21.65 Percentage of change in serum PGE2 level
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omega-3 polyunsaturated fatty acids (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum PGE2 Levels |
4.44; -21.65 | — |
| PRIMARY Change in Esophageal Tissue PGE2 Levels |
0.82; 11.87 | — |
| SECONDARY Change in Esophageal Macrophage Markers |
4.81; 2.12; 4.19; 2.00; 1.91; -0.53 | — |
Summary
This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.
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.
- 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
Data sourced from ClinicalTrials.gov (NCT01733147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.