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

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ClinicalTrials.gov Identifier: NCT01733147
Recruitment Status : Recruiting
First Posted : November 26, 2012
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):

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)
Estimated 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 : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733147


Contacts
Contact: Michele L Johnson 507 255-8692 johnson.michele@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele L Johnson    507-255-8692    johnson.michele@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Prasad Iyer, MD Mayo Clinic
More Information

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01733147     History of Changes
Other Study ID Numbers: 12-005914
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Prasad G. Iyer, Mayo Clinic:
Barrett's esophagus
Obesity
Omega-3 fatty acid

Additional relevant MeSH terms:
Inflammation
Barrett Esophagus
Pathologic Processes
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases