title: Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory bowel disease: a pilot study.
abstract: BACKGROUND
  The prebiotic potential of lactulose is well established and preclinical studies demonstrated a protective effect of lactulose in murine models of colitis. The aim of the present study was to investigate the clinical and histological efficacy of lactulose in patients with inflammatory bowel disease (IBD), for which probiotic therapy yielded promising results.
  
  
  METHODS
  Patients were treated with standard medication alone or combined with 10 g lactulose daily as adjuvant therapy for 4 months. Clinical efficacy of treatment was assessed using clinical activity indices, a quality of life index (IBDQ), endoscopic scores, defecation frequency and monitoring corticosteroid medication. Orsomucoid, alpha1-antitrypsin and other laboratory parameters were determined. In addition, in some participants colonic biopsies were analyzed with haematoxylin-eosin staining or with antibodies against HLA-DR, CD68, IgA and CD3, and evaluated systematically. All measurements were performed both at enrollment and at the end of the trial.
  
  
  RESULTS
  14 patients presenting ulcerative colitis (UC) and 17 patients presenting Crohn's disease (CD), most of them in a clinically active state, were enrolled in this pilot study. After 4 month no significant improvement of clinical activity index, endoscopic score or immunohistochemical parameters was observed in CD or UC patients receiving lactulose in comparison to the control group. However, significant improvement of quality of life was observed in UC patients receiving lactulose compared to the control group (p = 0.04).
  
  
  CONCLUSIONS
  The findings of the present pilot study indicate that oral lactulose has no beneficial effects in IBD patients in particular with regard to clinical activity, endoscopic score or immunohistochemical parameters. The importance of the beneficial effect of lactulose in UC patients regarding the quality of life needs further evaluation in larger controlled clinical trials.
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Medical School of Hannover, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Hafer.Anne@mh-hannover.de
authors.forename: Anne
authors.initials: A
authors.lastname: Hafer
authors.forename: Sigrid
authors.initials: S
authors.lastname: Krämer
authors.forename: Swantje
authors.initials: S
authors.lastname: Duncker
authors.forename: Martin
authors.initials: M
authors.lastname: Krüger
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
authors.forename: Stephan C
authors.initials: SC
authors.lastname: Bischoff
mesh_terms: D000328:Adult; D015703:Antigens, CD / Q000032:analysis; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D003106:Colon / Q000276:immunology / Q000473:pathology; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D003672:Defecation / Q000187:drug effects; D004359:Drug Therapy, Combination; D004724:Endoscopy; D005243:Feces / Q000737:chemistry; D005260:Female; D005753:Gastric Mucosa / Q000276:immunology / Q000473:pathology; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007150:Immunohistochemistry; D007792:Lactulose / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires