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

Purpose

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	Intervention	Phase
Barrett's Esophagus Obesity	Drug: Omega-3 free fatty acids Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders Obesity

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

changes in esophageal inflammation [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
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:

variation of changes in esophageal tissue [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	20
Study Start Date:	November 2012
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Subjects will be placed on 3 capsules a day of placebo (1000 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 Subjects with Barrett's esophagus. Baseline assessment: measure waist and hip circumference, height, weight. Complete the Reflux Symptom Questionnaire (RSQ). 10cc of blood drawn after 12 hour fast for serum free fatty acid (FFA) profile. Clinical baseline blood drawn: INR, LDL, AST and ALT. Endoscopy performed: four biopsies obtained from the GE junction and 4 biopsies from the BE mucosa. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects (presence and grade) and reinforce compliance. Compliance will also be assessed by pill counts during monthly call. Subjects will undergo repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a fasting blood draw for serum FFA profile, LDL, AST, ALT, INR and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the Reflux Symptom Questionnaire (RSQ). Other Name: Placebo
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 1000 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.	Drug: Omega-3 free fatty acids Subjects with Barrett's esophagus. Baseline assessment: measure waist and hip circumference, height, weight. Complete the Reflux Symptom Questionnaire (RSQ). 10cc of blood drawn after 12 hour fast for serum free fatty acid (FFA) profile. Clinical baseline blood drawn: INR, LDL, AST and ALT. Endoscopy performed: four biopsies obtained from the GE junction and 4 biopsies from the BE mucosa. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects (presence and grade) and reinforce compliance. Compliance will also be assessed by pill counts during monthly call. Subjects will undergo repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a fasting blood draw for serum FFA profile, LDL, AST, ALT, INR and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the Reflux Symptom Questionnaire (RSQ). Other Names: DHA/EPA Omega-3 fatty acid ethyl esters Ocean Blue® Professional Omega-3 2100™

Arms

Assigned Interventions

Placebo Comparator: Placebo

Subjects will be placed on 3 capsules a day of placebo (1000 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

Subjects with Barrett's esophagus. Baseline assessment: measure waist and hip circumference, height, weight. Complete the Reflux Symptom Questionnaire (RSQ). 10cc of blood drawn after 12 hour fast for serum free fatty acid (FFA) profile. Clinical baseline blood drawn: INR, LDL, AST and ALT. Endoscopy performed: four biopsies obtained from the GE junction and 4 biopsies from the BE mucosa. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects (presence and grade) and reinforce compliance. Compliance will also be assessed by pill counts during monthly call. Subjects will undergo repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a fasting blood draw for serum FFA profile, LDL, AST, ALT, INR and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the Reflux Symptom Questionnaire (RSQ).

Other Name: Placebo

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 1000 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.

Drug: Omega-3 free fatty acids

Subjects with Barrett's esophagus. Baseline assessment: measure waist and hip circumference, height, weight. Complete the Reflux Symptom Questionnaire (RSQ). 10cc of blood drawn after 12 hour fast for serum free fatty acid (FFA) profile. Clinical baseline blood drawn: INR, LDL, AST and ALT. Endoscopy performed: four biopsies obtained from the GE junction and 4 biopsies from the BE mucosa. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects (presence and grade) and reinforce compliance. Compliance will also be assessed by pill counts during monthly call. Subjects will undergo repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a fasting blood draw for serum FFA profile, LDL, AST, ALT, INR and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the Reflux Symptom Questionnaire (RSQ).

Other Names:

DHA/EPA
Omega-3 fatty acid ethyl esters
Ocean Blue® Professional Omega-3 2100™

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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 or as supplement.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733147

Contacts

Contact: Kelly Dunagan, RN

507 255-8692

dunagan.kelly@mayo.edu

Locations

United States, Minnesota
Mayo Clinic in Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kelly Dunagan, RN 507-255-8692 dunagan.kelly@mayo.edu

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Prasad Iyer, MD

Mayo Clinic

More Information

No publications provided

Responsible Party:	Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01733147 History of Changes
Other Study ID Numbers:	12-005914
Study First Received:	November 20, 2012
Last Updated:	January 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Barrett's esophagus
Obesity
Omega-3 fatty acid

Additional relevant MeSH terms:

Barrett Esophagus
Inflammation
Obesity
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013