Effect of a Probiotic Preparation (VSL#3) on Induction and Maintenance of Remission in Children With Ulcerative Colitis
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.
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The probiotic mixture VSL#3 reduces ulcerative colitis symptoms in adults and induces remission in children.
“In IBD, the probiotic mixture VSL#3, which contains bifidobacteria of different species, was able to reduce the UC symptoms in adults (144, 145) as well as the remission of the disease in children (84).”
From Bifidobacteria and Their Health-Promoting Effects (2017) · cites this paper as [84]
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- Authors
- Miele, E., Pascarella, F., Giannetti, E., Quaglietta, L., Baldassano, R. N., & Staiano, A.
- Affiliations
- University of Naples Federico II (IT)
- Federico II University Hospital (IT)
- Children's Hospital of Philadelphia (US)
- Corresponding author
- Staiano, Annamaria
- Venue
- The American Journal of Gastroenterology
- Published
- 2009-01-20
- Volume
- 104
- Issue
- 2
- Pages
- 437-443
- ISSN
- 0002-9270 (ISSN-L)
- 1572-0241
- OpenAlex
- W2041633812
- Cited by
- 517
- References
- 37
- Citations by year
- 2026: 7 · 2025: 16 · 2024: 29 · 2023: 24 · 2022: 30 · 2021: 33 · 2020: 32 · 2019: 21 · 2018: 26 · 2017: 31 · 2016: 27 · 2015: 44 · 2014: 39 · 2013: 37 · 2012: 43
- FWCI
- 23.06
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- ulcerative colitis, VSL#3, probiotics, children, remission induction, remission maintenance, recurrence, 5-aminosalicylic acid, corticosteroids, inflammatory bowel disease, safety and tolerability, disease activity assessment, pediatric inflammatory bowel disease, relapse prevention
- MeSH terms
- Adolescent, Anti-Inflammatory Agents, Child, Child, Preschool, Colitis, Ulcerative, Colonoscopy, Double-Blind Method, Female, Follow-Up Studies, Humans, Infant, Male, Prospective Studies, Recurrence, Remission Induction, Treatment Outcome, Probiotics
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