Article (Scientific journals)
Multicenter randomized-control led clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn's disease after ileo-caecal resection
Van Gossum, André; Dewit, Olivier; Louis, Edouard et al.
2007In Inflammatory Bowel Diseases, 13 (2), p. 135-142
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Keywords :
Crohn's disease; endoscopic recurrence; probiotics
Abstract :
[en] 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.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Van Gossum, André
Dewit, Olivier
Louis, Edouard  ;  Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie
de Hertogh, Geert
Baert, Filip
Fontaine, Fernand
Devos, Martine ;  Centre Hospitalier Universitaire de Liège - CHU > Oncologie médicale
Enslen, Marc
Paintin, Marc
Franchimont, Denis
Language :
English
Title :
Multicenter randomized-control led clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn's disease after ileo-caecal resection
Publication date :
February 2007
Journal title :
Inflammatory Bowel Diseases
ISSN :
1078-0998
eISSN :
1536-4844
Publisher :
John Wiley & Sons Inc, Hoboken, United States - New Jersey
Volume :
13
Issue :
2
Pages :
135-142
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 26 October 2009

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