Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733147
• Other study ID #: 12-005914
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: September 12, 2018

Study information

• Verified date: December 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Esophagitis
• Inflammation
• Obesity

Intervention

Drug:
• Omega-3 polyunsaturated fatty acids
3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ?3 FFA preparation containing 675 mg EPA and 300 mg DHA.
• Placebo
3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials