P0643Advancing 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 a guideline-recommended induction therapy for the treatment of Crohn’s disease (CD), with emerging evidence for partial enteral nutrition (PEN) in certain situations. However, such studies examining these dietary interventions do not necessarily follow stringent trial protocols to prove efficacy. We aimed to evaluate the methodological and reporting quality of interventional EEN and PEN trials to treat CD, and provide key recommendations to improve future study design. Methods Electronic databases were searched for interventional EEN and PEN trials in CD. Prospective studies using EEN or PEN as an interventional diet therapy were appraised for design, cohort definition, intervention details, adherence assessment, treatment efficacy nutritional outcomes, and reporting quality. Results Heterogeneity was observed across EEN/PEN trials. Most studies were single-centred and underpowered. Methodological failings were identified, with the majority of studies lacking: • A control comparator; • intervention description, including formula type, duration, caloric targets for PEN or reporting of concurrent diets for PEN; • objective disease markers, such as CRP, faecal calprotectin, endoscopy, radiologic findings; • adherence assessment, such as dietitian assessment or direct enquiry; and • markers of nutritional adequacy, such as anthropometrics, body composition or malnutrition screening Key recommendations to enhance rigour and reproducibility of EEN and PEN study design in future studies are outlined in Figure 1. Conclusion EEN and PEN trials vary in methodology and reporting, limiting interpretation of clinical efficacy. Implementations of key recommendations will strengthen the quality of EEN and PEN trials. Conflict of interest: Ms. Melton, Sarah: No conflict of interest Fitzpatrick, Jessica A.: No conflict of interest Chu, Matthew: No conflict of interest Gkikas, Konstantinos: PhD studentship funded in part from Nestle Health Science. Monro, Emily: No conflict of interest Matthews, Jemma: No conflict of interest Halmos, Emma: Grant: Intoleran Pty Ltd, Mindset Health Pty Ltd, NHMRC Investigator Grant, Crohn’s & Colitis Foundation Litwin IBD Pioneers Program, GESA IBD Clinical Project Award, Coeliac UK research grant, Coeliac Australia research grant, Monash University Australian Postgraduate Award Personal Fees: Consultant for: Ferring, Janssen, Abbvie, Takeda, Shire, Dr Falk Pharma Honorarium from: Ferring, Janssen, Abbvie, Takeda, Shire, Sandoz Conference support from Ferring Day, Alice: Research Support from The Hospital Research Foundation and Michelle McGrath Fellowship, consultancy fees from Biome Bank, Ferring, AbbVie.