Advancing Clinical Trial Methodology and Reporting of Outcomes for Exclusive Enteral Nutrition and Partial Enteral Nutrition in Crohn's Disease: Challenges and Recommendations

ABSTRACT Background Exclusive enteral nutrition (EEN) is an efficacious therapy for active Crohn's disease (CD), particularly in the paediatric setting. Aim This review critically evaluates key elements of interventional EEN trials in paediatric and adult cohorts to identify areas for improvement in trial design and reporting of outcomes, with additional consideration of emerging partial enteral nutrition (PEN) trials. Methods Electronic databases were searched for interventional EEN and PEN trials in CD. Prospective primary studies and trials were included if they used EEN or PEN as an interventional diet therapy in people with CD. Results There was considerable heterogeneity in trial design and EEN/PEN protocols, including the methodology, cohorts included and their description, assessment and reporting of adherence, assessment of efficacy, outcome measures and monitoring. As a result, there are limitations to advancing scientific knowledge in this area. Although interventional EEN and PEN trials should adhere to the same standards as other IBD therapy trials, a unique set of nutrition‐specific considerations are identified. Conclusion A practical set of recommendations is outlined from the authors' perspective to inform the design, conduct and reporting of future EEN/PEN trials to raise the rigour and quality of evidence for the use of these therapies in paediatric and adult cohorts.