Trial Outcomes & Findings for Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids (NCT NCT01733147)

NCT ID: NCT01733147

Last Updated: 2022-01-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline, 6 months
• Results posted on: 2022-01-11

Participant Flow

Participant milestones

Measure	Placebo 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. 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.	Omega-3 Polyunsaturated Fatty Acids 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. 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 ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo n=30 Participants 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. 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.	Omega-3 Polyunsaturated Fatty Acids n=30 Participants 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. 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 ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.	Total n=60 Participants Total of all reporting groups
Age, Continuous	66 years n=30 Participants	66.5 years n=30 Participants	66 years n=60 Participants
Sex: Female, Male Female	5 Participants n=30 Participants	11 Participants n=30 Participants	16 Participants n=60 Participants
Sex: Female, Male Male	25 Participants n=30 Participants	19 Participants n=30 Participants	44 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

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

Outcome measures

Measure	Placebo n=30 Participants 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. 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.	Omega-3 Polyunsaturated Fatty Acids n=30 Participants 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. 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 ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.
Change in Serum PGE2 Levels	4.44 Percentage of change in serum PGE2 level Interval -33.2 to 59.06	-21.65 Percentage of change in serum PGE2 level Interval -59.64 to 5.07

PRIMARY outcome

Timeframe: Baseline, 6 months

Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection

Outcome measures

Measure	Placebo n=30 Participants 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. 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.	Omega-3 Polyunsaturated Fatty Acids n=30 Participants 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. 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 ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.
Change in Esophageal Tissue PGE2 Levels	0.82 Percentage of change in esophageal PGE2 Interval -52.98 to 132.95	11.87 Percentage of change in esophageal PGE2 Interval -44.81 to 33.58

SECONDARY outcome

Timeframe: Baseline, 6 months

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

Outcome measures

Measure	Placebo n=30 Participants 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. 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.	Omega-3 Polyunsaturated Fatty Acids n=30 Participants 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. 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 ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.
Change in Esophageal Macrophage Markers MCP-1 (Pro-inflammatory, M1 marker)	4.81 Percentage change in macrophage markers Interval -0.27 to 12.47	2.12 Percentage change in macrophage markers Interval -4.8 to 17.25
Change in Esophageal Macrophage Markers CD 206 (Anti-inflammatory, M2 marker)	4.19 Percentage change in macrophage markers Interval 0.0 to 7.51	2.00 Percentage change in macrophage markers Interval -0.46 to 5.04
Change in Esophageal Macrophage Markers IL-10 (Anti-inflammatory M2 marker)	1.91 Percentage change in macrophage markers Interval -0.87 to 3.27	-0.53 Percentage change in macrophage markers Interval -3.25 to 1.06

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Omega-3 Polyunsaturated Fatty Acids

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=30 participants at risk 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. 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.	Omega-3 Polyunsaturated Fatty Acids n=30 participants at risk 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. 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 ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.
Gastrointestinal disorders Mild nausea	3.3% 1/30 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.	0.00% 0/30 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.
Gastrointestinal disorders Diarrhea	0.00% 0/30 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.	6.7% 2/30 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.

Additional Information

Dr. Prasad Iyer

Mayo Clinic

Phone: 507-293-7911

Email: iyer.Prasad@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place