Article

Effect of a Probiotic Preparation (VSL# 3) on Induction and Maintenance of Remission in Children With Ulcerative Colitis

Department of Pediatrics, University of Naples "Federico II", Naples, Italy.
The American Journal of Gastroenterology (Impact Factor: 9.21). 02/2009; 104(2):437-43. DOI: 10.1038/ajg.2008.118
Source: PubMed

ABSTRACT Several probiotic compounds have shown promise in the therapy of ulcerative colitis (UC). However, a strong sustained benefit remains to be seen. Uncontrolled pilot studies suggest that a probiotic preparation (VSL#3) maintains remission in mild to moderate UC and reduces active inflammation in adult patients. Aims of our prospective, 1-year, placebo-controlled, double-blind study were to assess the efficacy of VSL#3 on induction and maintenance of remission and to evaluate the safety and tolerability of the probiotic preparation therapy in children with active UC.
A total of 29 consecutive patients (mean age: 9.8 years; range: 1.7-16.1 years; female/male: 13/16) with newly diagnosed UC were randomized to receive either VSL#3 (weight-based dose, range: 450-1,800 billion bacteria/day; n=14) or an identical placebo (n=15) in conjunction with concomitant steroid induction and mesalamine maintenance treatment. Children were prospectively evaluated at four time points: within 1 month, 2 months, 6 months, and 1 year after diagnosis or at the time of relapse. Lichtiger colitis activity index and a physician's global assessment were used to measure disease activity. At baseline, within 6 months and 12 months or at the time of relapse, all patients were assessed endoscopically and histologically.
All 29 patients responded to the inflammatory bowel disease (IBD) induction therapy. Remission was achieved in 13 patients (92.8%) treated with VSL#3 and IBD therapy and in 4 patients (36.4%) treated with placebo and IBD therapy (P<0.001). Overall, 3 of 14 (21.4%) patients treated with VSL#3 and IBD therapy and 11 of 15 (73.3%) patients treated with placebo and IBD therapy relapsed within 1 year of follow-up (P=0.014; RR=0.32; CI=0.025-0.773; NNT=2). All 3 patients treated with VSL#3 and 6 of 11 (54.5%) patients treated with placebo relapsed within 6 months of diagnosis. At 6 months, 12 months, or at time of relapse, endoscopic and histological scores were significantly lower in the VSL#3 group than in the placebo group (P<0.05). There were no biochemical or clinical adverse events related to VSL#3.
This is the first pediatric, randomized, placebo-controlled trial that suggests the efficacy and safety of a highly concentrated mixture of probiotic bacterial strains (VSL#3) in active UC and demonstrates its role in maintenance of remission.

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    • "As probiotics showed a positive functionality on oxidative stress-related indices, they can help both to stabilize and to promote the potency of the whole body antioxidative defense system and thus in turn may have an impact on lowering the risk of several inflammatory metabolic disorders including IBDs. Besides this, a large body of evidence also suggests that probiotics, like VSL#3 and L. rhamnosus GG, could serve as the promising candidates for the prevention and control of IBD although some conflicting results have also been reported [16] [17] [18] [19] [20]. "
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    ABSTRACT: Based on the preliminary screening of eight indigenous putative probiotic Lactobacilli, Lactobacillus fermentum Lf1 was selected for assessing its antioxidative efficacy in DSS colitis mouse model based on its ability to enhance the expression of "Nrf2" by 6.43-fold and malondialdehyde (MDA) inhibition by 78.1 ± 0.24% in HT-29 cells under H2O2 stress. The Disease Activity Index and histological scores of Lf1-treated mice were lower than the control group. However, expression of "Nrf2" was not observed in Lf1-treated mice. A significant increase in the expression of antioxidative enzymes such as SOD2 and TrxR-1 was recorded in both of the groups. The expression of SOD2 was significantly downregulated in colitis-induced mice by -100.00-fold relative to control group, and the downregulation was considerably reduced to -37.04-fold in colitis Lf1 treatment group. Almost, a similar trend was recorded in case of "thioredoxin" expression, though "CAT" was refractile to expression. The Lf1-treated group had decreased malondialdehyde level as compared to colitis control (37.92 ± 6.31 versus 91.13 ± 5.76 μM/g). These results point towards Lf1-induced activation of the antioxidant enzyme system in the mouse model and its prospects to be explored as a new strategy for IBD management.
    BioMed Research International 07/2014; 2014:206732. DOI:10.1155/2014/206732 · 2.71 Impact Factor
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    • "As probiotics showed a positive functionality on oxidative stress-related indices, they can help both to stabilize and to promote the potency of the whole body antioxidative defense system and thus in turn may have an impact on lowering the risk of several inflammatory metabolic disorders including IBDs. Besides this, a large body of evidence also suggests that probiotics, like VSL#3 and L. rhamnosus GG, could serve as the promising candidates for the prevention and control of IBD although some conflicting results have also been reported [16] [17] [18] [19] [20]. "
    BioMed Research International 01/2014; · 2.71 Impact Factor
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    • "Bifidobacterium longum plus psyllium Yes 28 d/2 × 10 9 CFU per day and 4 g of psyllium twice daily Oral Synbiotic treatment improved the quality of life better than probiotic or prebiotic treatment Miele et al., 2009 [23] RDBPCT 29 1.7–16.1 Children newly diagnosed with UC * VSL#3 Yes 365 d/4.5 × 10 11 –1.8 × 10 12 CFU per day Oral VSL#3 was safe and effective in children treated for active UC * * Hegazy and El-Bedewy, 2010 [68] RCT 45 47 (mean age) Mild to moderate UC patients with chronic diarrhea * Lacteol Yes 56 d/1 ×10 10 CFU per day Oral Supplementation with probiotics could be advantageous in preventing relapse of UC and maintaining remission "
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