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Omega-3 Supplements for Lynch Syndrome
Study Summary
This trial will study the effects of a fish oil supplement on changes in the gut microbiome of people at high risk for colorectal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with Lynch Syndrome.I agree to stop taking Aspirin for 4 weeks before and during the trial.I am currently on blood thinners.I haven't taken omega 3 or flaxseed supplements in the last 4 weeks.I am currently taking aspirin for reasons other than cancer prevention.I am willing to have two colonoscopies and biopsies, one now and another in a year.You are allergic to fish or fish products.My organs and bone marrow are working well.I am fully active or can carry out light work.I regularly take NSAIDs for pain or inflammation.I have no active cancers except for non-melanoma skin cancers or any cured cancer with no signs of return in over 5 years.I cannot swallow or keep down pills.I, or my legal representative, can understand the study and agree to sign the consent form.I have a condition that affects how my stomach or intestines absorb food, or I've had surgery on these organs.I will use two forms of birth control or practice abstinence during and 90 days after the study.I have not taken high doses of omega 3 fatty acids in the last 3 months.I have a genetic condition or inflammatory bowel disease.I am scheduled for a planned endoscopy procedure.I do not have any uncontrolled infections.I agree not to father a child or donate sperm during and for 3 months after the study.
- Group 1: Omega-3, 2 grams
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are enrolled in the current clinical trial?
"Unfortunately, the recruitment period for this trial has ended. Initially posted on February 6th 2019 and updated November 7th 2022; those interested in similar studies can find 2,444 trials recruiting patients with Lynch Syndrome and 20 clinical trials testing Omega-3 fatty acid ethyl esters (2 gram)."
Has the FDA approved Omega-3 fatty acid ethyl esters (2 gram) for use?
"Our team has determined that Omega-3 fatty acid ethyl esters (2 gram) are likely safe, with a score of 2 due to the fact this is a Phase 2 trial; while there exists some data demonstrating safety, no evidence yet confirms efficacy."
Has there ever been a comparable research project to this one?
"Presently, there are 20 live clinical trials for Omega-3 fatty acid ethyl esters (2 gram) located in 11 states and 9 countries. Abbott's 2005 trial involving 15480 participants was the first of its kind to receive Phase 4 drug approval; since then a total of 163 such studies have been finalized."
Is recruitment for this investigation being conducted at the present?
"The trial, which was first posted on the 6th of February 2019 and last modified on November 7 2022, is not accepting new participants at this moment. However, 2464 other studies are actively recruiting patients right now."
Are there any comparable studies to the clinical trial involving Omega-3 fatty acid ethyl esters (2 gram)?
"Currently, there are 20 clinical trials for Omega-3 fatty acid ethyl esters (2 gram) with 5 of those studies in their last phase. Despite the majority being conducted from Boston, Massachusetts; 36 different sites have opened up studies related to this medication."
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