Barrett's EsophagusPhase 4NCT01733147
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
A Phase 4 study testing Omega-3 polyunsaturated fatty acids in people with Barrett's Esophagus and Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Barrett's Esophagus, Obesity
- What is being tested?
- Omega-3 polyunsaturated fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 12 Sep 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study
This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.
- Conditions
- Barrett's Esophagus, Obesity
- Being tested
- Omega-3 polyunsaturated fatty acids, Placebo
- Keywords
- Omega-3 fatty acid
- Medical subject headings
- Barrett Esophagus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 polyunsaturated fatty acidsDrug
Also called Docosahexaenoic Acid (DHA)/Eicosapentaenoic Acid (EPA)
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Omega-3 polyunsaturated fatty acids | Active comparator | 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. Receives: Drug: Omega-3 polyunsaturated fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum PGE2 Levels
Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw
Measured: Baseline, 6 months
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
Measured: Baseline, 6 months
Secondary outcomes (1)
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
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startNov 2012
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prasad G. Iyer, Mayo Clinic
- Investigators
- Prasad Iyer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733147
- Sponsor's protocol ID
- 12-005914
- Status last verified
- Dec 2021
- First submitted
- 20 Nov 2012
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01733147
- Acronym / sponsor ID
- 12-005914
- Conditions
- Barrett's Esophagus, Obesity
- Keywords
- Omega-3 fatty acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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. |
| Omega-3 polyunsaturated fatty acids | Active comparator | Drug: Omega-3 polyunsaturated fatty acidsSubjects 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 polyunsaturated fatty acidsAlso: Docosahexaenoic Acid (DHA)/Eicosapentaenoic Acid (EPA)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. | Drug | Omega-3 polyunsaturated fatty acids |
| Placebo3 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. | Drug | Placebo |
Primary outcome
Change in Serum PGE2 Levels
Time frame: Baseline, 6 months
Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw
Change in Esophageal Tissue PGE2 Levels
Time frame: Baseline, 6 months
Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection
1 secondary outcome
Change in Esophageal Macrophage Markers
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Barrett's Esophagus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasad Iyer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 polyunsaturated fatty acids in people with Barrett's Esophagus and Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum PGE2 Levels (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.