Hypothesis Summary
Two of the best treatment options currently available to people with Crohn’s disease are drug injections known as biologics, and a liquid-only diet in the form of specially formulated milkshakes, known as Exclusive Enteral Nutrition (EEN), commonly used as a first line treatment to induce remission in paediatric patients.
However, treatment with biologics is only successful in approximately 40-50% of patients, and although treatment with EEN has a better safety and effectiveness profile, eliciting clinical remission in up to 80% of patients, it is difficult for patients to adhere to. Patients find it difficult to consume the milkshakes as their sole source of nutrition for the advised 6-8 weeks due to various factors, including poor palatability and interference with social activities.
In the BIOPIC study, we want to investigate whether replacing part of the diet with the specialised milkshakes, known as Partial Enteral Nutrition (PEN), will improve response to standard treatment with biologics in adults with active Crohn’s disease.
Previous studies have demonstrated that replacing at least 50% of the diet with PEN considerably increases disease remission rates compared to an unrestricted diet and may improve response rates and minimise the loss of treatment response when combined with other pharmaceutical interventions, including standard care treatment with biologics. Theoretically, utilising PEN as an adjunctive therapy also mitigates compliance issues associated with complete dietary restriction and improves treatment efficacy, reducing the use of other pharmaceutical interventions with harmful side-effects. Ultimatly, this increases patients quality of life.
The BINGO group is actively 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 a maximum of 6 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 for up to 1-year post-intervention.
During the study, we will collect blood, urine, saliva and stool samples and information about the patients’ diet.
The samples will be used to measure responses to biologic therapy, changes in disease markers and gut bacteria. 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 the treatment with specialised milkshakes for half the participants diet and biologics.