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

• ClinicalTrials.gov Identifier: NCT01733147
• Recruitment Status: Active, not recruiting
• First Posted: November 26, 2012
• Last Update Posted: July 2, 2020
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Prasad G. Iyer, Mayo Clinic

Study Description

Brief Summary:

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?

Condition or disease	Intervention/treatment	Phase
Barrett's Esophagus; Obesity	Drug: Omega-3 free fatty acids; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Modulation of Esophageal Inflammation in Barrett&Apos;s Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study
• Study Start Date: November 2012
• Estimated Primary Completion Date: January 2021
• Estimated Study Completion Date: June 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Subjects will be placed on 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months. Subjects will take 2 capsules with breakfast and 1 capsule with their evening meal.	Drug: Placebo; Baseline assessment: Measure waist and hip circumference, height, weight. Complete Gastroesophageal Reflux Questionnaire (GERQ). Blood draw for serum free fatty acid (FFA) profile. Clinical baseline blood draw: INR, LDL, AST and ALT. Single slice CT of abdomen. Endoscopy performed with biopsies, brushings, and mucosal impedance testing. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects and reinforce compliance. Repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a blood draw as outlined at baseline, and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the GERQ.
Active Comparator: Omega-3 free fatty acids; Subjects will be placed on 3 capsules a day of Omega 3 free fatty acids taken orally for six months. Subjects will take 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.	Drug: Omega-3 free fatty acids; Baseline assessment: Measure waist and hip circumference, height, weight. Complete Gastroesophageal Reflux Questionnaire (GERQ). Blood draw for serum free fatty acid (FFA) profile. Clinical baseline blood draw: INR, LDL, AST and ALT. Single slice CT of abdomen. Endoscopy performed with biopsies, brushings, and mucosal impedance testing. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects and reinforce compliance. Repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a blood draw as outlined at baseline, and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the GERQ.; Other Names: DHA/EPA; Omega-3 fatty acid ethyl esters; Ocean Blue® Professional Omega-3 2100™

Outcome Measures

Primary Outcome Measures :

1. changes in esophageal inflammation [ Time Frame: baseline and 6 months ]
   Specific Aim 1: To estimate the magnitude and variation of changes in esophageal inflammation and injury in Barrett's esophagus as measured by tissue PGE2 and the esophageal inflammation score, attributable to ω3 FFA supplementation.

Secondary Outcome Measures :

1. variation of changes in esophageal tissue [ Time Frame: baseline and 6 months ]
   Specific Aim 2: To estimate the magnitude and variation of changes in esophageal macrophage infiltration and modulation of esophageal macrophage phenotype attributable to ω3 FFA supplementation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Prasad Iyer, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01733147
• Other Study ID Numbers: 12-005914
• First Posted: November 26, 2012
• Last Update Posted: July 2, 2020
• Last Verified: July 2020

Keywords provided by Prasad G. Iyer, Mayo Clinic:

Barrett's esophagus; Obesity; Omega-3 fatty acid

Additional relevant MeSH terms:

Barrett Esophagus; Esophagitis; Inflammation; Pathologic Processes; Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis