Clinical trial · Interventional
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study
NCT01733147CI-TRIAL-00055894completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omega-3 polyunsaturated fatty acids | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Omega-3 polyunsaturated fatty acids
- description
- Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.
- interventionNames
- Drug: Omega-3 polyunsaturated fatty acids
Primary outcomes (2)
- measure
- Change in Serum PGE2 Levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.