In children diagnosed with congenital, developmental or GI conditions, COMPLEAT® PEDIATRIC Peptide 1.5 formula made with fruit and vegetable ingredients was found to be well tolerated.

Introduction

Enteral nutrition (EN) provides nutrition support to patients with a functional gastrointestinal (GI) tract who are unable to meet nutrition goals by mouth. Peptide-based enteral tube feeding (ETF) formulas are designed for malabsorption, impaired GI function, or enteral intolerance, and have shown improved tolerance compared with standard polymeric formulas.^1-3 There is a growing body of evidence on improved GI tolerance with peptide-based ETF as well as formulas containing real food ingredients.^3,4 However, evidence on peptide- and plant-based ETF also containing fruit and vegetable ingredients is scarce.

Objectives

To assess clinical outcomes related to GI intolerance in children receiving a peptide- and plant-based ETF formula containing a variety of fruit and vegetable ingredients in post-acute care.

Methods

This retrospective study of de-identified data was conducted using nationally representative US claims data obtained from the Decision Resources Group Real World Evidence Data Repository, which provides longitudinal patient-level electronic health record, as well as medical and pharmacy claims data including more than 300 million patients. Post-acute patients 1-13 years prescribed a peptide- and plant-based (hydrolyzed pea protein) formula with fruit and vegetable ingredients (Compleat^® Pediatric Peptide 1.5 [PPF], Nestlé HealthCare Nutrition, US) between January 2020 and December 2022 were included. The index date was defined as the date of hospital discharge, the pre-index period was defined as six months prior to the index date, and the post-index periods were 28, 84 and 168 days after the index date. GI intolerance symptoms at pre- and post-index periods were compared.

Patient Characteristics

The study included 91 children (49% female; mean age 5.5 (SD±3) years) from all US regions. The most common pre-index comorbidities were congenital conditions (73%), developmental delays (60%), and GI conditions (57%). Among 89 patients (98%) with at least one comorbidity, the mean (SD) pediatric comorbidity index (PCI) score was 7.4 (3.5).⁵ A large proportion of patients (n=76, 84%) had a PCI weighted score ≥4.

Results

Significantly fewer (23% vs 56%) patients experienced any GI intolerance symptoms at 28 days post-index when receiving PPF formula compared to pre-index (p<0.001). This reduction in GI intolerance symptoms was maintained at 84 days (29% vs 56%) and 168 days (32% vs 56%) post-discharge (p<0.001), see Table below. Significant reductions in individual GI intolerance symptoms of constipation, diarrhea, nausea and vomiting were also significantly reduced across all post-index time periods (p<0.05).