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

Primary Purpose

Barrett's Esophagus, Obesity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omega-3 polyunsaturated fatty acids
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett's Esophagus focused on measuring Omega-3 fatty acid

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Omega-3 polyunsaturated fatty acids

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Serum PGE2 Levels
Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw
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

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2012
Last Updated
December 13, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01733147
Brief Title
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
Official Title
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus, Obesity
Keywords
Omega-3 fatty acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Omega-3 polyunsaturated fatty acids
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Omega-3 polyunsaturated fatty acids
Other Intervention Name(s)
Docosahexaenoic Acid (DHA)/Eicosapentaenoic Acid (EPA)
Intervention Description
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 ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Serum PGE2 Levels
Description
Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw
Time Frame
Baseline, 6 months
Title
Change in Esophageal Tissue PGE2 Levels
Description
Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in Esophageal Macrophage Markers
Description
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
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad Iyer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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