Trial Design

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The Screening Trial is planned to start Summer 2024. This is a randomised controlled trial aiming to recruit 120,000 people with heartburn over a three-year period.   Men aged 55-79 and women aged 65-79 taking regular acid-suppressant medications living in select areas in England may be invited via text message to participate in BEST4. 

People will be identified by NHS England data and initially invited via text message to join a Heartburn Health Programme bioresource and then asked to complete a survey about heartburn-related symptoms and PPI prescriptions to assess eligibility and enrol to the BEST4 Screening Trial. The trial will compare standard care (N=80,000) with the Capsule sponge test, with 40,000 participants attending mobile units in the community for the test.

After a diagnosis of Barrett’s oesophagus, it is crucial to establish an effective surveillance strategy that balances ongoing monitoring with the burden on endoscopy services. The BEST4 Surveillance Trial aims to assess the feasibility of integrating the Capsule sponge and a clinical laboratory biomarker panel into the surveillance approach for patients with non-dysplastic Barrett’s oesophagus. This combined strategy has the potential to reduce the reliance on frequent endoscopy procedures, leading to substantial cost savings for the NHS while ensuring appropriate monitoring for patients with Barrett’s oesophagus. 

Eligible people include those undergoing routine endoscopic surveillance with known Barrett’s or those diagnosed with Barrett’s as part of the BEST4 Screening Trial. We will aim to recruit a total of 2000 people over 2 years. 

Participants will receive the capsule sponge test in addition to their standard of care endoscopy as part of Barrett’s oesophagus surveillance during this 3-year trial. All sponge samples will undergo laboratory immunohistochemistry test to evaluate the presence of specific biomarkers such as TFF3, p53 and atypia. These tests are used for risk stratification, which helps determine recommended endoscopic interval for participants.