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Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis.
Am J Gastroenterol. 2009 Feb; 104(2):437-43.AJ

Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

Department of Pediatrics, University of Naples "Federico II", Naples, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19174792

Citation

Miele, Erasmo, et al. "Effect of a Probiotic Preparation (VSL#3) On Induction and Maintenance of Remission in Children With Ulcerative Colitis." The American Journal of Gastroenterology, vol. 104, no. 2, 2009, pp. 437-43.
Miele E, Pascarella F, Giannetti E, et al. Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. Am J Gastroenterol. 2009;104(2):437-43.
Miele, E., Pascarella, F., Giannetti, E., Quaglietta, L., Baldassano, R. N., & Staiano, A. (2009). Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. The American Journal of Gastroenterology, 104(2), 437-43. https://doi.org/10.1038/ajg.2008.118
Miele E, et al. Effect of a Probiotic Preparation (VSL#3) On Induction and Maintenance of Remission in Children With Ulcerative Colitis. Am J Gastroenterol. 2009;104(2):437-43. PubMed PMID: 19174792.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. AU - Miele,Erasmo, AU - Pascarella,Filomena, AU - Giannetti,Eleonora, AU - Quaglietta,Lucia, AU - Baldassano,Robert N, AU - Staiano,Annamaria, Y1 - 2009/01/20/ PY - 2009/1/29/entrez PY - 2009/1/29/pubmed PY - 2009/3/4/medline SP - 437 EP - 43 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 104 IS - 2 N2 - OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1572-0241 UR - https://www.unboundmedicine.com/medline/citation/19174792/Effect_of_a_probiotic_preparation__VSL L2 - http://Insights.ovid.com/pubmed?pmid=19174792 DB - PRIME DP - Unbound Medicine ER -