Exclusion diet vs. exclusion diet plus partial enteral nutrition in management of pediatric Crohn’s disease

BACKGROUND AND AIMS: Exclusive enteral nutrition (EEN) induces remission in children with active mild to moderate Crohn's disease (CD), while partial enteral nutrition (PEN) with a free diet have failed to be effective in these patients. The effects of CD exclusion diet (CDED) alone has not yet been evaluated in pediatric CD. The current study aimed to compare the effects of CDED alone vs. CDED plus PEN on children and adolescents with mild to moderate CD. METHODS: A prospective randomized trial was conducted on children with mild to moderate Crohn's Disease (CD), aged 4-18 years. Eligible children were included in the study based on the inclusion and exclusion criteria and after the approval of the diagnosis by a pediatric gastroenterologist. Patients were assigned to receive either CDED + PEN, or only CDED. The study evaluated remission, disease activity, inflammatory markers, anthropometric measurements, quality of life, fecal calprotectin (FC), and albumin after 8 weeks of intervention. RESULTS: Sixty patients were randomly assigned to two groups (30 to CDED + PEN group and 30 to CDED) and included in the analysis. At eight weeks, our analysis showed no significant difference in response (P = 0.92) and remission (P = 0.71) between two groups. However, both groups experienced remission rates of over 60%. The study found no differences in anthropometric measurements, inflammatory markers, disease activity and FC between groups, while CDED + PEN significantly improved quality of life. CONCLUSION: CDED is as effective as CDED plus PEN in induction of remission in active mild to moderate pediatric CD. TRIAL REGISTRATION: The study has been registered in protocol ID gov (NCT06353633, with a registration date of 20240204).