Study Design
The BINGO group will be recruiting patients with Crohn’s disease who require treatment with biologics. Patients will be split into two groups, whereby one group is provided with specialised milkshakes to replace half of their required food intake for six weeks and the other group continues to eat their normal habitual diet, alongside treatment with biologics. Both groups will be followed up for an initial period of 12 weeks, with disease activity monitored through their medical records for up to one-year post-intervention.
During the study, we collect blood, urine, saliva, and stool samples alongside information about the patients’ diet. The samples will be used to measure responses to biologic therapy, changes in the host immune system, and changes in the oral and gut bacteria as well as the metabolites they produce. The researchers will also compare gut bacteria and dietary habits between patients with Crohn’s disease and healthy controls to identify how these differ and how these change during treatment with biologics with or without the specialised milkshakes.
A subset of patients from both study groups will complete endoscopic procedures at baseline and after 12 weeks to allow us to assess mucosal healing as well as their mucosal immune and microbiome profile.