{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T18:08:07Z","timestamp":1790100487236,"version":"4.0.1"},"reference-count":33,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Patients after partial or total gastrectomy suffer from malnourishment and diminished quality of life (QOL). Due to altered physiological processes after gastric surgery, coordination between chyme and digestive enzymes produced by the pancreas is affected in many ways, finally leading to maldigestion and malabsorption. These in turn promote various symptoms such as discomfort or steatorrhea. Supplementation of digestive enzymes during food intake may improve digestion and decrease nutrition-related abdominal symptoms, finally leading to higher QOL. To date, trials examining the role of digestive enzyme supplementation in patients with gastrectomy are lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We designed a randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing QOL after 6 months of oral digestive enzyme supplementation vs. placebo in a sample of 188 patients after partial or total gastrectomy. Digestive enzymes or placebo are taken orally with the meals. Cancer specific QOL (physical sub-score from EORTC-QLQ-C30) at six months is the primary outcome. Secondary outcomes include other measures of QOL, weight loss, use of supplemental nutrition, and laboratory measurements related to malnutrition and metabolism.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This trial will help assess using digestive enzymes in patients with partial or total gastrectomy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec022\">\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      EU Trial Number: 2022-501944-14-00. Clinical Trial Number:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT06058442\" xlink:type=\"simple\">NCT06058442<\/jats:ext-link>\n                      (Registration date: 09\/08\/2023).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0358177","type":"journal-article","created":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T17:34:14Z","timestamp":1790098454000},"page":"e0358177","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Protocol of the PANEM trial: A randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing PANcreatic EnzyMes versus placebo in adults after gastrectomy"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-5946-2995","authenticated-orcid":true,"given":"Kevin","family":"Thomas","sequence":"first","affiliation":[{"name":"Leipzig University Medical Center","place":["Leipzig, Germany"],"department":["Department of Medicine, Neurology and Dermatology, Division of Oncology, Gastroenterology, Hepatology and Pneumology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Ackmann","sequence":"additional","affiliation":[{"name":"Leipzig University Medical Center","place":["Leipzig, Germany"],"department":["Department of Medicine, Neurology and Dermatology, Division of Oncology, Gastroenterology, Hepatology and Pneumology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anett","family":"Schmiedeknecht","sequence":"additional","affiliation":[{"name":"Leipzig University, Medical faculty","place":["Leipzig, Germany"],"department":["Clinical Trial Centre Leipzig"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathrin","family":"Scheibe","sequence":"additional","affiliation":[{"name":"Leipzig University, Medical faculty","place":["Leipzig, Germany"],"department":["Clinical Trial Centre Leipzig"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Kleemann","sequence":"additional","affiliation":[{"name":"Medical University of Lausitz - Carl Thiem","place":["Cottbus, Germany"],"department":["4th Medical Clinic for Gastroenterology and Rheumatology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Ardelt","sequence":"additional","affiliation":[{"name":"University Hospital Jena","place":["Jena, Germany"],"department":["Department of General, Visceral and Vascular Surgery"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Dondorf","sequence":"additional","affiliation":[{"name":"University Hospital Jena","place":["Jena, Germany"],"department":["Department of General, Visceral and Vascular Surgery"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Radulova-Mauersberger","sequence":"additional","affiliation":[{"name":"Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Dresden","place":["Dresden, Germany"],"department":["Department of Visceral"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmina","family":"Kuvendjiska","sequence":"additional","affiliation":[{"name":"University Medical Center Freiburg","place":["Freiburg, Germany"],"department":["Department of General and Visceral Surgery"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9291-9695","authenticated-orcid":true,"given":"Julian","family":"Hipp","sequence":"additional","affiliation":[{"name":"University Medical Center Freiburg","place":["Freiburg, Germany"],"department":["Department of General and Visceral Surgery"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Jansen-Winkeln","sequence":"additional","affiliation":[{"name":"Visceral, Thoracic and Vascular Surgery, St. George\u2019s Hospital Leipzig","place":["Leipzig, Germany"],"department":["Department of General"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Bley","sequence":"additional","affiliation":[{"name":"Visceral, Thoracic and Vascular Surgery, St. George\u2019s Hospital Leipzig","place":["Leipzig, Germany"],"department":["Department of General"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrike","family":"Wetzold","sequence":"additional","affiliation":[{"name":"Medical University of Lausitz - Carl Thiem","place":["Cottbus, Germany"],"department":["Department of Surgery"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Sporn","sequence":"additional","affiliation":[{"name":"Helios Hospital Schwerin","place":["Schwerin, Germany"],"department":["Department of General and Visceral Surgery"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franziska","family":"Peters","sequence":"additional","affiliation":[{"name":"Helios Hospital Schwerin","place":["Schwerin, Germany"],"department":["Department of General and Visceral Surgery"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"T\u00e9oule","sequence":"additional","affiliation":[{"name":"University Hospital Ulm","place":["Ulm, Germany"],"department":["Department of General and Visceral Surgery"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emrullah","family":"Birgin","sequence":"additional","affiliation":[{"name":"University Hospital Ulm","place":["Ulm, Germany"],"department":["Department of General and Visceral 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