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Multicenter randomized-control led clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn's disease after ileo-caecal resection

Andre Van Gossum, Olivier Dewit, Edouard Louis, Geert de Hertogh, Filip Baert, Fernand Fontaine, MARTINE DE VOS UGent, Marc Enslen, Marc Paintin and Denis Franchimont (2007) INFLAMMATORY BOWEL DISEASES. 13(2). p.135-142
abstract
Background: Seventy percent of Crohn's disease (CD) patients exhibit anastomotic recurrence within I year after ileo-caecal surgery, Recent clinical trials suggest the beneficial use of probiotics in the control of intestinal inflammation in pouchitis and ulcerative colitis. This study is a multicenter clinical trial evaluating the efficacy of an oral administration of the probiotic LA1 on early postoperative endoscopic recurrence of CD. Methods: Seventy patients with CD were enrolled prior to elective ileo-caecal resection and randomly assigned after surgery to daily treatment with either Lactobacillus johnsonii, LA1, Nestle (10(10) colony-forming units, CFU) (group A, n = 34) or placebo (group B, n = 36) for 12 weeks. The primary objective was to assess the effect of LA1 on the endoscopic recurrence rate at 12 weeks. Stratification was performed according to smoking status at randomization. Results: Seven and 14 patients were excluded in the LA1 and placebo groups, respectively. In intention-to-treat analysis, the mean endoscopic score was not significantly different between the two treatment groups at 3 months (LA1 versus placebo: 1.50 +/- 1.32 versus 1.22 +/- 1.37, treatment effect: P = 0.48, smoke effect: P = 0.72). The percentage of patients with severe recurrence (i3 + i4) was 21% and 15% in the LA1 and placebo groups, respectively (P = 0.33). Using a per-protocol (PP) analysis, the mean endoscopic score was not significantly different between the two treatment groups (LA1 versus placebo groups: 1.44 +/- 1.31 versus 1.05 +/- 1.21, P = 0.32). The percentage of patients with severe recurrence (i3 + i4) was 19% and 9% in the LA1 and placebo groups, respectively (P = 0.054). Clinical relapse rate (CDAI [CD activity index] > 150, with an increase of CDAI > 70 points or greater from baseline) in the LAI and placebo groups was 15% (4/27) and 13.5% (3/22), respectively (PP analysis: chi-square test, P = 0.91 and log-rank test: P = 0.79). Conclusion: Oral administration of the probiotic LA1 in patients with CID failed to prevent early endoscopic recurrence at 12 weeks after ileo-caecal resection.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (proceedingsPaper)
publication status
published
subject
keyword
ULCERATIVE-COLITIS, ESCHERICHIA-COLI, POSTOPERATIVE RECURRENCE, MAINTAINING REMISSION, PLACEBO-CONTROLLED TRIAL, HLA-B27 TRANSGENIC RATS, INFLAMMATORY-BOWEL-DISEASE, probiotics, endoscopic recurrence, Crohn's disease, MAINTENANCE TREATMENT, NATURAL-HISTORY, DOUBLE-BLIND
journal title
INFLAMMATORY BOWEL DISEASES
Inflamm. Bowel Dis.
volume
13
issue
2
pages
135 - 142
conference name
Digestive Disease Week Meeting ; 106th Annual meeting of the American Gastroenterological Association
conference location
Chicago, IL, USA
conference start
2005-05-14
conference end
2005-05-19
Web of Science type
Proceedings Paper
Web of Science id
000244166800003
JCR category
GASTROENTEROLOGY & HEPATOLOGY
JCR impact factor
4.705 (2007)
JCR rank
9/50 (2007)
JCR quartile
1 (2007)
ISSN
1078-0998
DOI
10.1002/ibd.20063
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
742474
handle
http://hdl.handle.net/1854/LU-742474
date created
2009-09-09 08:58:48
date last changed
2012-04-19 16:56:20
@article{742474,
  abstract     = {Background: Seventy percent of Crohn's disease (CD) patients exhibit anastomotic recurrence within I year after ileo-caecal surgery, Recent clinical trials suggest the beneficial use of probiotics in the control of intestinal inflammation in pouchitis and ulcerative colitis. This study is a multicenter clinical trial evaluating the efficacy of an oral administration of the probiotic LA1 on early postoperative endoscopic recurrence of CD.
Methods: Seventy patients with CD were enrolled prior to elective ileo-caecal resection and randomly assigned after surgery to daily treatment with either Lactobacillus johnsonii, LA1, Nestle (10(10) colony-forming units, CFU) (group A, n = 34) or placebo (group B, n = 36) for 12 weeks. The primary objective was to assess the effect of LA1 on the endoscopic recurrence rate at 12 weeks. Stratification was performed according to smoking status at randomization.
Results: Seven and 14 patients were excluded in the LA1 and placebo groups, respectively. In intention-to-treat analysis, the mean endoscopic score was not significantly different between the two treatment groups at 3 months (LA1 versus placebo: 1.50 +/- 1.32 versus 1.22 +/- 1.37, treatment effect: P = 0.48, smoke effect: P = 0.72). The percentage of patients with severe recurrence (i3 + i4) was 21\% and 15\% in the LA1 and placebo groups, respectively (P = 0.33). Using a per-protocol (PP) analysis, the mean endoscopic score was not significantly different between the two treatment groups (LA1 versus placebo groups: 1.44 +/- 1.31 versus 1.05 +/- 1.21, P = 0.32). The percentage of patients with severe recurrence (i3 + i4) was 19\% and 9\% in the LA1 and placebo groups, respectively (P = 0.054). Clinical relapse rate (CDAI [CD activity index] {\textrangle} 150, with an increase of CDAI {\textrangle} 70 points or greater from baseline) in the LAI and placebo groups was 15\% (4/27) and 13.5\% (3/22), respectively (PP analysis: chi-square test, P = 0.91 and log-rank test: P = 0.79).
Conclusion: Oral administration of the probiotic LA1 in patients with CID failed to prevent early endoscopic recurrence at 12 weeks after ileo-caecal resection.},
  author       = {Van Gossum, Andre and Dewit, Olivier and Louis, Edouard and de Hertogh, Geert and Baert, Filip and Fontaine, Fernand and DE VOS, MARTINE and Enslen, Marc and Paintin, Marc and Franchimont, Denis},
  issn         = {1078-0998},
  journal      = {INFLAMMATORY BOWEL DISEASES},
  keyword      = {ULCERATIVE-COLITIS,ESCHERICHIA-COLI,POSTOPERATIVE RECURRENCE,MAINTAINING REMISSION,PLACEBO-CONTROLLED TRIAL,HLA-B27 TRANSGENIC RATS,INFLAMMATORY-BOWEL-DISEASE,probiotics,endoscopic recurrence,Crohn's disease,MAINTENANCE TREATMENT,NATURAL-HISTORY,DOUBLE-BLIND},
  language     = {eng},
  location     = {Chicago, IL, USA},
  number       = {2},
  pages        = {135--142},
  title        = {Multicenter randomized-control led clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn's disease after ileo-caecal resection},
  url          = {http://dx.doi.org/10.1002/ibd.20063},
  volume       = {13},
  year         = {2007},
}

Chicago
Van Gossum, Andre, Olivier Dewit, Edouard Louis, Geert de Hertogh, Filip Baert, Fernand Fontaine, MARTINE DE VOS, Marc Enslen, Marc Paintin, and Denis Franchimont. 2007. “Multicenter Randomized-control Led Clinical Trial of Probiotics (Lactobacillus Johnsonii, LA1) on Early Endoscopic Recurrence of Crohn’s Disease After Ileo-caecal Resection.” Inflammatory Bowel Diseases 13 (2): 135–142.
APA
Van Gossum, A., Dewit, O., Louis, E., de Hertogh, G., Baert, F., Fontaine, F., DE VOS, M., et al. (2007). Multicenter randomized-control led clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn’s disease after ileo-caecal resection. INFLAMMATORY BOWEL DISEASES, 13(2), 135–142. Presented at the Digestive Disease Week Meeting ; 106th Annual meeting of the American Gastroenterological Association.
Vancouver
1.
Van Gossum A, Dewit O, Louis E, de Hertogh G, Baert F, Fontaine F, et al. Multicenter randomized-control led clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn’s disease after ileo-caecal resection. INFLAMMATORY BOWEL DISEASES. 2007;13(2):135–42.
MLA
Van Gossum, Andre, Olivier Dewit, Edouard Louis, et al. “Multicenter Randomized-control Led Clinical Trial of Probiotics (Lactobacillus Johnsonii, LA1) on Early Endoscopic Recurrence of Crohn’s Disease After Ileo-caecal Resection.” INFLAMMATORY BOWEL DISEASES 13.2 (2007): 135–142. Print.