The effect of omega-3 fatty acids on Barrett's oesophagus

Phase 1

• Conditions: Barrett's oesophagus refers to changes in the lining of the lower oesophagus in response to injury caused by gastric reflux. It is a pre-malignant condition and has a well established link with adenocarcinoma of the oesophagus which is increasing in frequency in western countries. Although not everyone will progress to cancer, there is as yet no established medical therapy which will reverse the process.; MedDRA version: 9.1 Level: LLT Classification code 10004134 Term: Barrett's esophagus; MedDRA version: 9.1 Level: LLT Classification code 10004136 Term: Barrett's oesophagitis with dysplasia

• Registration Number: EUCTR2007-001034-14-GB
• Lead Sponsor: St George's Healthcare NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-14
• Study Completion: 2009-09-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Any patient, male or female, aged 18+ undergoing endoscopic surveillance for Barrett's oesophagus.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. Patients who are allergic to fish (cannot take tablets)
·Pregnant or breast-feeding patients (although there is no known harm associated with the capsules we are not keen to give them to pregnant people in case of unknown harmful effects)
. Patients with a bleeding diathesis/disorder
·Patients who are taking warfarin or other anticoagulants (excluding aspirin) - (EPA can interact with warfarin and increase bleeding risk)
. Patients with known gastrointestinal malabsorption
·Patients with known dysplasia at previous endoscopy
·Patients who are taking other fish-oil supplements (eg cod liver oil) who are unwilling to stop them for the duration of the study
·Patients deemed mentally incompetent.
·Patients considered by their physician unlikely to be able to comply with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified