{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T15:47:15Z","timestamp":1792684035064,"version":"4.5.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T00:00:00Z","timestamp":1792627200000},"content-version":"vor","delay-in-days":48,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"The Insides Company Ltd"},{"name":"Databean Inc."},{"name":"GLCC Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Patients with type 2 intestinal failure due to double enterostomy or enterocutaneous fistula requiring parenteral nutrition (PN), are at higher risks of catheter sepsis, venous thrombosis, and liver disease. Chyme reinfusion therapy (CRT) may reduce PN dependence but has not been evaluated in a randomized clinical trial. This study assessed whether device-assisted CRT using The Insides\u00ae System reduces PN requirements.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This multicentre, open-label randomized clinical trial enrolled PN-dependent adults with type 2 intestinal failure due to double enterostomy or enterocutaneous fistula across 12 centres in the UK and USA between 2022 and 2025. Patients with insufficient distal limb length, proximal bowel obstruction, active sepsis, or severe hepatorenal failure were excluded. Participants were block randomized 2 : 1 to device-assisted CRT plus standard care (active) or standard care (control). The primary endpoint was \u2265 50% reduction in PN caloric intake at 30\u2005days, using an intention-to-treat analysis, for a comparison between randomized groups using a two-tailed P value of 0.025 to allow for a single interim analysis. Secondary outcomes were rate of PN cessation at 30 and 60\u2005days, quality of life, and adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Out of 44 patients assessed for eligibility, 39 patients were randomized (26 CRT plus standard care\u2014active, 13 standard care control). At day 30, 8 of 26 active participants (31%) achieved the primary endpoint versus no controls (P = 0.035). By day 60, 10 of 23 active participants (42%) had completely ceased PN versus no controls (P = 0.011), with median intestinal losses reduced by 1344\u2005ml\/day at day 30 (P = 0.005) and 1450\u2005ml\/day at day 60 (P = 0.026 between group). There were 11 device-related adverse events, one severe and all resolved. There was one death unrelated to the device.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Although the study\u2019s primary endpoint did not reach statistical significance, at 30\u2005days, 31% of participants undergoing CRT had reduced PN calories by 50%, and at 60\u2005days &amp;gt; 40% of CRT patients had completely ceased PN, with an acceptable safety profile.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration number<\/jats:title>\n                    <jats:p>NCT04577456 (http:\/\/www.clinicaltrials.gov).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjsopen\/zrag158","type":"journal-article","created":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T11:49:27Z","timestamp":1786535367000},"source":"Crossref","is-referenced-by-count":0,"title":["Chyme reinfusion using The Insides\u00ae System to reduce parenteral nutrition dependence in type 2 intestinal failure: multicentre randomized clinical trial (REINFUSE)"],"prefix":"10.1093","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5838-8077","authenticated-orcid":false,"given":"Tony G E","family":"Milne","sequence":"first","affiliation":[{"name":"Department of Colorectal Surgery, Royal Brisbane and Women\u2019s Hospital , Brisbane, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Lal","sequence":"additional","affiliation":[{"name":"Gastroenterology, Northern Care Alliance NHS Foundation Trust , Manchester ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arun","family":"Abraham","sequence":"additional","affiliation":[{"name":"Gastroenterology, Northern Care Alliance NHS Foundation Trust , Manchester ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirstine","family":"Farrer","sequence":"additional","affiliation":[{"name":"Gastroenterology, Northern Care Alliance NHS Foundation Trust , Manchester ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Evans","sequence":"additional","affiliation":[{"name":"Colorectal Surgery, Nottingham University Hospitals NHS Trust , Nottingham ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Thomas","sequence":"additional","affiliation":[{"name":"Colorectal Surgery, Nottingham University Hospitals NHS Trust , Nottingham ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolynne","family":"Vaizey","sequence":"additional","affiliation":[{"name":"Colorectal Surgery, London North West University Healthcare NHS Trust , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Gabe","sequence":"additional","affiliation":[{"name":"Colorectal Surgery, London North West University Healthcare NHS Trust , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Layfield","sequence":"additional","affiliation":[{"name":"Colorectal Surgery, University Hospital Southampton NHS Foundation Trust , Southampton ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neena","family":"Randhawa","sequence":"additional","affiliation":[{"name":"Colorectal Surgery, Newcastle Hospitals NHS Foundation Trust , Newcastle ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Rogers","sequence":"additional","affiliation":[{"name":"Gastrolenterology, Royal Devon University Healthcare NHS Foundation Trust , Exeter ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David F","family":"Mercer","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Nebraska Medical Center , Omaha ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liran","family":"Barda","sequence":"additional","affiliation":[{"name":"Trauma Surgery, University of Miami Health System , Miami ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert E","family":"Carroll","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology, University of Illinois Chicago , Chicago ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin D","family":"Rosenthal","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Florida , Gainesville ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed-Mohammed","family":"Jafri","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology, Henry Ford Health , Detroit ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Frampton","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Otago , Christchurch, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4342-7464","authenticated-orcid":false,"given":"Dermot","family":"Burke","sequence":"additional","affiliation":[{"name":"Abdominal Medicine & Surgery, Leeds Teaching Hospitals NHS Trust , Leeds 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