title: Multicentre, randomised, placebo-controlled trial of extract of Japanese herbal medicine Daikenchuto to prevent bowel dysfunction after adult liver transplantation (DKB 14 Study).
abstract: BACKGROUND
  This multicentre randomised controlled clinical trial will aim to determine the ability of an extract (TJ-100) of Daikenchuto (traditional Japanese herbal medicine; Kampo) to prevent bowel dysfunction in at least 110 patients after liver transplantation (LT).
  
  
  METHODS
  The following co-primary end points will be evaluated on postoperative day 7: total oral and enteral caloric intake, abdominal distension and abdominal pain. The secondary end points will comprise sequential changes of total oral and enteral caloric intake after LT, sequential changes in numeric rating scales for abdominal distension and pain, elapsed time to the first postoperative passage of stool, quality of life assessment using the Gastrointestinal Symptom Rating Scale score (Japanese version), postoperative liver function, liver regeneration rate, incidence of bacteraemia and bacterial strain, trough level of immunosuppressants, occurrence of acute cellular rejection, discharge or not within 2 months after LT, sequential changes of portal venous flow to the graft and ascites discharge. The two arms of the study will comprise 55 patients per arm.
  
  
  BACKGROUND
  The study has been conducted according to the CONSORT statement. All participants signed a written consent form, and the study has been approved by the institutional review board of each participating institute and conducted in accordance with the Declaration of Helsinki of 1996. The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals.
  
  
  BACKGROUND
  The DKB 14 Study was registered in the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan (registration number: UMIN000014326) during 2014.
authors.affiliation: Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Toshimi
authors.initials: T
authors.lastname: Kaido
authors.affiliation: Division of Organ Transplantation, Hokkaido University Hospital, Sapporo, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Shimamura
authors.affiliation: Artificial Organ and Transplantation Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Sugawara
authors.affiliation: Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sadamori
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Shirabe
authors.affiliation: Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Michio
authors.initials: M
authors.lastname: Yamamoto
authors.affiliation: Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Uemoto
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D002149:Energy Intake / Q000187:drug effects*; D005260:Female; D029001:Herbal Medicine; D006801:Humans; D007418:Intestinal Pseudo-Obstruction / Q000188:drug therapy* / Q000517:prevention & control; D007564:Japan / Q000453:epidemiology; D016031:Liver Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D005894:Panax; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control; D011184:Postoperative Period; D011788:Quality of Life; D016896:Treatment Outcome; D032106:Zanthoxylum; D030521:Zingiberaceae
chemical_list: D010936:Plant Extracts; C121414:dai-kenchu-to
keywords: NUTRITION & DIETETICS; TRANSPLANT SURGERY