Gastrointestinal response and weight outcomes with a hypercaloric, plant- and food-based formula in pediatric tube-fed patients: A short-term exploratory study.

INTRODUCTION: Food-based enteral formulas are increasingly being used for children with medical complexity and are associated with improved feeding tolerance. However, feed volumes needed to meet energy needs may not be tolerated. This study monitored short-term gastrointestinal (GI) and weight outcomes after initiating a commercial hypercaloric, plant- and food-based, formula in tube-fed children with medical complexities. METHODS: In this exploratory study, tube-fed children aged 1-13 years were recruited from outpatient clinics at a tertiary care hospital (May 2023-June 2024). Participants received study formula (1.5 kcal/mL) exclusively for 14 days with additional water to meet total fluid needs. Caregivers recorded data about feed administration, as well as any change to GI symptoms and bowel movements, daily. Weight-for-age and BMI-for-age z-scores were compared at baseline and end-of-study using Wilcoxon signed rank tests. The percentage of energy achieved versus prescribed, as well as protein (g/kg/day) intake compared to Dietary Reference Intakes for sex and age, was assessed. RESULTS: Twenty-six participants (median age 5.5 years, 59% male) completed the study. After two weeks on the study formula, a modest increase in mean weight-for-age and BMI-for-age z-scores was observed (p<0.01). There were no significant changes to GI symptoms or bowel movements reported. Participants achieved 100% of prescribed energy for nearly all study days (13±1.7 days) and exceeded daily protein requirements. Caregivers (84.6%) reported high satisfaction with the study formula. CONCLUSION: Short-term administration of a commercial hypercaloric, plant- and food-based formula that met prescribed energy and protein needs was associated with modest weight increase and no changes to baseline GI symptoms or bowel movements. These findings suggest that hypercaloric food-based enteral nutrition products are generally tolerated in stable, medically complex, tube-fed children. Larger, prolonged studies are needed to evaluate long-term tolerance and nutritional adequacy.