{
  "abstract": "Background: 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. Methods: 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. Discussion: This trial will help assess using digestive enzymes in patients with partial or total gastrectomy. Trial Registration: EU Trial Number: 2022-501944-14-00. Clinical Trial Number: NCT06058442 (Registration date: 09/08/2023).",
  "abstract_shown": true,
  "affiliations": [
    "Department of Medicine, Neurology and Dermatology, Division of Oncology, Gastroenterology, Hepatology and Pneumology, Leipzig University Medical Center, Leipzig, Germany",
    "Clinical Trial Centre Leipzig, Leipzig University, Medical faculty, Leipzig, Germany",
    "4th Medical Clinic for Gastroenterology and Rheumatology, Medical University of Lausitz - Carl Thiem, Cottbus, Germany",
    "Department of General, Visceral and Vascular Surgery, University Hospital Jena, Jena, Germany",
    "Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Dresden, Dresden, Germany",
    "Department of General and Visceral Surgery, University Medical Center Freiburg, Freiburg, Germany",
    "Department of General, Visceral, Thoracic and Vascular Surgery, St. George’s Hospital Leipzig, Leipzig, Germany",
    "Department of Surgery, Medical University of Lausitz - Carl Thiem, Cottbus, Germany",
    "Department of General and Visceral Surgery, Helios Hospital Schwerin, Schwerin, Germany",
    "Department of General and Visceral Surgery, University Hospital Ulm, Ulm, Germany"
  ],
  "article_type": "Study Protocol",
  "arxiv": null,
  "author_total": 19,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Kevin Thomas"
    },
    {
      "affs": [
        1
      ],
      "name": "Charlotte Ackmann"
    },
    {
      "affs": [
        2
      ],
      "name": "Anett Schmiedeknecht"
    },
    {
      "affs": [
        3
      ],
      "name": "Kathrin Scheibe"
    },
    {
      "affs": [
        4
      ],
      "name": "Tobias Kleemann"
    },
    {
      "affs": [
        5
      ],
      "name": "Michael Ardelt"
    },
    {
      "affs": [
        6
      ],
      "name": "Felix Dondorf"
    },
    {
      "affs": [
        7
      ],
      "name": "Olga Radulova-Mauersberger"
    },
    {
      "affs": [
        8
      ],
      "name": "Jasmina Kuvendjiska"
    },
    {
      "affs": [
        9
      ],
      "name": "Julian Hipp"
    },
    {
      "name": "Boris Jansen-Winkeln"
    },
    {
      "name": "Thomas Bley"
    },
    {
      "name": "Ulrike Wetzold"
    },
    {
      "name": "Judith Sporn"
    },
    {
      "name": "Franziska Peters"
    },
    {
      "name": "Patrick Téoule"
    },
    {
      "name": "Emrullah Birgin"
    },
    {
      "name": "David Petroff"
    },
    {
      "name": "Albrecht Hoffmeister"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/cs76t0w3rt1mk.bib",
  "cited_by": 0,
  "doi": "10.1371/journal.pone.0358177",
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  "id": "cs76t0w3rt1mk",
  "issns": [
    "1932-6203"
  ],
  "landing_url": "https://doi.org/10.1371/journal.pone.0358177",
  "language": null,
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
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      "openalex",
      "2916|Clinical Nutrition and Gastroenterology"
    ],
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      "plos",
      "/Biology and life sciences/Anatomy/Endocrine system/Pancreas"
    ],
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    ],
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      "/Biology and life sciences/Biochemistry/Proteins/Enzymes/Digestive enzymes"
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      "/Medicine and health sciences/Anatomy/Exocrine glands/Pancreas"
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      "/Medicine and health sciences/Surgical and invasive medical procedures/Digestive system procedures"
    ],
    [
      "plos",
      "/Medicine and health sciences/Surgical and invasive medical procedures/Digestive system procedures/Gastrectomy"
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      "/Research and analysis methods/Research design/Clinical research design/Adverse events"
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  "pdf_url": "https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0358177&type=printable",
  "pmcid": null,
  "pmid": null,
  "published": "2026-09-22",
  "publisher": "Public Library of Science",
  "ris": "https://research.draconitic.com/paper/cs76t0w3rt1mk.ris",
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    {
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  "subjects": [
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      "origin": "plos:nutrition",
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  "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:17:43Z",
  "url": "https://research.draconitic.com/paper/cs76t0w3rt1mk",
  "venue": "PLOS One",
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