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 50-60% 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.
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. Ultimately, this increases patients’ quality of life.
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.