Van GA, Dewit O, Louis E, et al.. Multicenter randomized-controlled clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn's disease after lleo-caecal resection

Vrije Universiteit Brussel, Bruxelles, Brussels Capital, Belgium
Inflammatory Bowel Diseases (Impact Factor: 4.46). 02/2007; 13(2):135-42. DOI: 10.1002/ibd.20063
Source: PubMed


Seventy percent of Crohn's disease (CD) patients exhibit anastomotic recurrence within 1 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 LAl on early post-operative endoscopic recurrence of CD.
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 (1010 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 LAl on the endoscopic recurrence rate at 12 weeks. Stratification was performed according to smoking status at randomization.
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 LAl 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 (LAl 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 LAl 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 LAl 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).
Oral administration of the probiotic LA1 in patients with CD failed to prevent early endoscopic recurrence at 12 weeks after ileo-caecal resection.

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Available from: Filip Baert, Nov 10, 2014
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    • "Nowadays, there is focus on their beneficial effects on human and animal health. They are used for elimination of problems related to digestion and uptake of nutrition; for instance, they modulate the composition of gastrointestinal microbiota and function of host immune system ; moderate the postantibiotic (Sepp et al. 2011) and traveler's diarrhea (Lin et al. 2009), lactose intolerance (Ibarra et al. 2012), inflammatory bowel diseases (Crohn's disease (Van Gossum et al. 2007), ulcerative colitis (Schultz et al. 2004)), and hypercholesterolemia (Simons et al. 2006). The health benefits are strain dependent, and therefore, accurate identification and differentiation of each strain is essential prior to probiotic application. "
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    ABSTRACT: Several biochemical and molecular methods were used for discrimination of four Lactobacillus reuteri strains isolated from goatling and lamb stomach mucosa. Internal transcribed spacer (ITS)-PCR method and protein analysis by SDS-PAGE and MALDI-TOF showed to be suitable for strain discrimination whereas ITS-PCR/RFLP and enterobacterial repetitive intergenic consensus (ERIC)-PCR were not strain specific. The used methods differentiated tested strains into distinct groups; however, the location of strains in groups varied. Consistency in results was observed in the case of L. reuteri E and L. reuteri KO4m that were clustered into the same groups using all techniques, except of MALDI-TOF MS. The last one grouped goatling strains and lamb isolate into separate clusters. All investigated methods, except of ITS-PCR/RFLP and ERIC-PCR, were assessed as appropriate for distinguishing of L. reuteri strains.
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    • "Two notable exceptions preserve hope for probiotics in the treatment of CD. Yeast S. boulardii was shown to be more effective than melsalazine in maintaining remission of CD (Guslandi et al., 2000) and improving intestinal permeability in CD patients (Van Gossum et al., 2007). Probiotic mixture VSL#3 was successful in the treatment of CD-induced arthralgia (Karimi et al., 2005) and in the prevention of postoperative recurrence of CD (Madsen et al., 2008). "

    Full-text · Chapter · Jan 2012
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    • "More controlled studies have been performed on the maintenance of remission in adults with CD (Table 4), but in general these studies fail to show any benefit of probiotic administration [Schultz et al. 2004; Guslandi et al. 2000; Malchow, 1997]. Data are even more robust on the prevention of relapse following surgical intervention, but again probiotics fail to prevent endoscopic or clinical recurrence (Table 4) [Chermesh et al. 2007; Van Gossum et al. 2007; Marteau et al. 2006; Prantera et al. 2002]. Several meta-analyses and systematic reviews have shown that probiotics were ineffective in maintenance of remission in CD [Rahimi et al. 2008; Rolfe et al. 2006]. "
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    ABSTRACT: Perturbation of bacterial microflora of the gastrointestinal (GI) tract may play an important role in the pathophysiology of some GI disorders. Probiotics have been used as a treatment modality for over a century. They may restore normal bacterial microflora and effect the functioning of the GI tract by a variety of mechanisms. Probiotics are not currently regulated and only few randomized controlled trials exist investigating their efficacy in different GI disorders. They are available in a variety of formulations and delivery systems making interpretation and comparison of studies even more difficult. The efficacy of probiotics, either as a single strain or a combination of probiotics, has been tested in antibiotic-associated diarrhea, Clostridium difficile colitis, infectious diarrhea, ulcerative colitis, Crohn's disease, pouchitis, and irritable bowel syndrome, among other disorders. Results of the studies are reviewed in this article and recommendations for probiotic use in these disorders are made. Although probiotics appear to be generally safe in an outpatient setting, the situation may be different in immunocompromised, hospitalized patients who may be at a greater risk of developing probiotic sepsis. No studies exist addressing the issue of safety specifically. Many questions regarding use of probiotics in GI disorders remain to be answered in future studies, such as most optimal doses, duration of treatment, physiological and immunological effects, efficacy of specific probiotics in specific disease states, and safety in debilitated patients.
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