OBJECTIVES:Neonatal and pediatric intestinal failure related to enterostomy is an infrequent but burdensome condition associated with substantial morbidity and mortality. This study presents the development and clinical validation of a novel device to resolve these problems, by formalizing a safe and efficient enterostomy chyme reinfusion technique. METHODS:A novel neonatal chyme reinfusion device was designed and manufactured ('The Insides Neo', The Insides Company, New Zealand), prior to validation in a feasibility study in tertiary neonatal intensive care centres. Neonates with double enterostomy were recruited and commenced on chyme reinfusion therapy using the novel device to test safety, efficacy, tolerability, and usability within nursing workflows. Device and clinical outcomes were recorded along with nursing feedback. Registered under the ANZCTR, identifier no. ACTRN12621000835842p. RESULTS:Ten neonates were recruited across two centres, with a median usage duration of 37.5 (range 12-84) days. Following initiation of therapy, rate of weight gain increased from mean 68.8 ± 37.4 to 197 ± 25.0 g/week (p = 0.024). Of the 7/10 neonates on PN at commencement of therapy, 4/7 were able to wean and achieve enteral autonomy. All neonates tolerated the device with uniformly positive nursing feedback and minimal time to learn and incorporate the novel device into nursing workflows. There were no device-related adverse events. CONCLUSIONS:A novel device was developed and validated to be safe and effective at performing chyme reinfusion therapy in neonates. This device is anticipated to improve the clinical care and outcomes of neonatal patients with double enterostomies.

Rationale: Intestinal failure associated liver disease (IFALD) associated with parenteral nutrition (PN), is defined as hepatobiliary dysfunction with elevated liver function tests (LFT), resulting from medical/surgical management of intestinal failure (IF). High output stoma losses and IF from necrotising enterocolitis (NEC) is prevalent. PN risks include gut and hepatobiliary dysfunction and IFALD that can progress to end-stage liver disease, but chyme reinfusion therapy (CRT) that facilitates intestinal adaptation can stabilise LFT. Methods: Review the potential for CRT to improve nutrition status and normalise LFT, specifically, aspartate aminotransferase (ASP), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and serum bilirubin (BIL) in recent clinical studies Results: Adult Studies by Picot et al showed that in 237 paired IF patients with LFT >2X normal, CRT reduced AST from 29% to 13%, ALT 11% to 4%, ALP 48% to13% and GGT 81%to 40%. One or more LFT abnormalities decreased from 83% to 40% (p < 0.0001). In their later CRT study, PN stopped in 9/10 patients within 3 days. ALP and GGT significantly reduced after 49 days (P<0.001 and P = 0.003, respectively) but declining trends in ALT, AST and BIL were statistically insignificant. In a NZ study of 10 adult IF patients, 80% weaned early from PN with improvement in ALP -123 U/L (p=0.05) and GGT -290 U/L (p =0.268). In a systematic review of paediatric CRt experiences, 7/11 studies reported reductions in ALP, GGT and in BIL after CRT (155 vs. 275 μmol/L; p<0.001). Preliminary data in 5 NEC patients (mean wt 1.9 kg) confirm improvements in LFT with 46 % wt gain after 2-4 weeks using a novel system for paediatric CRT (Insides Neo™). Conclusion: Fistuloclysis with CRT can wean adult IF and paediatric NEC patients from PN, leading to earlier oral feeding and improved nutritional status. CRT reestablishes small intestinal continuity and normalises LFT, potentially by restoring hepatic bile salt synthesis with consequent improvement in NEC, IFALD and improved gut–liver health. The influence of chyme on absorption of bile salts, nutrients, microbiota, and on IFALD needs further investigations. References: Picot D et al Nutrients 2020:12;1376 Bhat S et al Clin Nutr ESPEN 2020:37;1-8 Disclosure of Interest: T. Harrington: None declared, E. Ludlow Consultant for: none, R. Davidson Shareholder at: confidential, G. Hardy Consultant for: unpaid

Introduction: Enterocutaneous fistulae are a common cause of intestinal failure, and may necessitate parenteral nutrition (PN) and prolonged hospitalisation. Refeeding of fistula losses back into the distal gut is known to be beneficial, however implementation has been limited because devices are not commonly available, and manual recycling is unpleasant and labour-intensive. We present a novel device designed to enable easy and efficient chyme recycling, and report data from a first-in-human feasibility study. Methods: The novel device comprises a compact centrifugal pump that can be placed inside a standard stoma bag. The pump is connected to an intestinal feeding tube which is inserted into the distal fistula limb. The pump is activated across the stoma bag by magnetic coupling to a custom-designed hand-held driver unit, effecting intermittent bolus refeeding while avoiding contact with the stoma effluent. Five speed settings were included to handle different chyme viscosities. Nutritional, medical, psychological and human-use factors were evaluated in an initial feasibility study. Results: Following benchtop validation, the device was tested in 10 patients (1 drop-out due to unrelated obstruction; median 31d; IQR 22-50d). Indications for inclusion were remediation of high-output fistula / stoma losses (n=7), dependency on PN (n=5), and gut rehabilitation prior to restoration of continuity (n=10). A range of chyme viscosities were successfully recycled with increasing efficiency over the course of the trial, due to iterative device improvements. Patients consumed low residue diets. Once established, chyme recycling was well-tolerated in all patients, using regular boluses of up to 200 ml per episode, performed as many times as needed per day. Patients experienced a variety of benefits including reduced net losses (>65% average volumes), PN cessaton (4/5 patients, including all patients employing the final device iteration), liver function improvement, electrolyte normalisation, and improved quality of life. Of 6 patients with continuity restored at the time of reporting, none experienced post-operative ileus. Conclusions: A novel chyme recycling device was developed and feasibility confirmed in an initial study. The device is easy to use and demonstrates multiple potential benefits including weaning of PN, gut rehabilitation, improved surgical outcomes, and reduced costs of care in these complex patients. A larger efficacy trial is currently planned.