Barrett’s oESophagus Trial 4 (BEST4): a randomised control trial comparing capsule sponge test screening to usual care
Barrett's oesophagus
Current interventions as of 27/07/2026: The BEST4 Screening study aims to recruit 120,000 people (men aged 55-79 years and women aged 65-79 years) with heartburn over a two-and-a-half-year period. This recruitment will take place across different Regional Research Delivery Networks (RRDNs) and Devolved Nations. Identification of suitable patients for inclusion will be handled by NHS Digitrials and iPLATO, a trusted NHS primary care digital patient engagement provider. NHS Digitrials (or devolved nations equivalent) will employ the specified inclusion and exclusion criteria via in their search of the NHSE Patient Demographic Service (or devolved nations equivalent) for data extracts for the invitation process. Patients will be initially invited to join the 'Heartburn Health Programme'. The programme will establish the Bioresource and also act as the first stage of participant identification. Participants will be invited to join the programme, by iPLATO, via one of two routes: 1. SMS text messages 2. Self-enrolment Upon consenting to join the programme, participants will be asked if they would be interested in a capsule sponge test if it was available locally. Those that express interest will be randomised at a 2:1 ratio, control and intervention arm, respectively. Those in the control arm (n = 80,000) will not be contacted again nor consented to the Screening trial (Zelen design). Those in the investigational arm (n = 40,000) will then be invited to book an appointment on a local mobile unit in order to have the capsule sponge test. The qualified healthcare professionals and mobile units used in the trial will be provided by EMS healthcare. For the intervention cohort, those who attend an appointment will provide informed consent before carrying out any procedures. Participants will have the opportunity to discuss the nature and objectives of the trial, and possible risks associated with their participation with a member of the Cambridge Clinical team (prior to th
Current inclusion criteria as of 07/10/2025: Heartburn Health Programme: 1. Have given electronic informed consent to participate 2. UK resident 3. Males aged 55 - 79 years and Females aged 65 - 79 years (sex at birth) 4. Have a mobile phone number 5. Patient reported symptoms and/or use medication for heartburn, acid reflux and indigestion. Screening Trial: 1. Meet same criteria as Heartburn Health 2. Patient reported regular symptoms of heartburn, acid reflux and indigestion in the last 6 months AND/OR 3. Confirmed regular use of a prescription or over the counter acid-suppressant medication in the last 6 months 4. Express interest in a capsule sponge test _____ Previous inclusion criteria: Heartburn Health Programme: 1. Have given electronic informed consent to participate 2. Males aged 55 - 79 years and Females aged 65 - 79 years (sex at birth) 3. Have a mobile phone number 4. Self-confirmed symptoms of heartburn, acid reflux and indigestion Screening Trial: 5. Meet same criteria as Heartburn Health 6. Self-confirmed regular use (biweekly) of a prescription or over-the-counter acid-suppressant medication in the last 6 months
Current exclusion criteria as of 07/10/2025: Screening Trial: 1. Patient reported difficulty swallowing pills 2. Patient reported previous diagnosis of BO 3. Patient reported upper GI endoscopy in the last 3 years 4. Patient reported Cytosponge/capsule sponge procedure in the last 3 years 5. Patient reported diagnosis of oesophageal cancer 6. Patient reported prior surgical intervention to the oesophagus or upper stomach _____ Previous exclusion criteria: Screening Trial: 1. Patient-reported a previous diagnosis of BO confirmed on histology 2. Patient-reported upper GI endoscopy in the last 5 years 3. Patient-reported Cytosponge/Capsule Sponge procedure in the last 5 years 4. Meet the guidelines for an urgent endoscopy referral according to NICE guidelines (dyspepsia with acute GI bleed, dyspepsia that fails to respond to PPI or H2R antagonist with negative Helicobacter Pylori test, unintentional weight loss, persistent vomiting, iron deficiency anaemia, epigastric mass, suspicious barium meal indicating risk of cancer) 5. Recorded diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour (T2 staging and above), or symptoms of dysphagia 6. Difficulty in swallowing due to a known cerebrovascular accident or neurological disorder 7. Recorded oesophageal varices, cirrhosis of the liver, portal hypertension 8. Received prior endoscopic (photodynamic therapy or radiofrequency ablation) or surgical intervention to the oesophagus 9. Inability to temporarily discontinue anti-thrombotic medication prior to the procedure as per clinical JAG guidelines 10. Known pregnancy 11. Lack of capacity to provide informed consent 12. Procedural: Having eaten or drank within the last 4 hours