VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study - PubMed (original) (raw)
Randomized Controlled Trial
VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study
Stefano Guandalini et al. J Pediatr Gastroenterol Nutr. 2010 Jul.
Abstract
Background and objectives: : Irritable bowel syndrome (IBS) is a common problem in pediatrics, for which no safe and effective treatment is available. Probiotics have shown some promising results in adult studies, but no positive study has been published on pediatric age. We aimed at investigating the efficacy of VSL#3 in a population of children and teenagers affected by IBS, in a randomized, double-blind, placebo-controlled, crossover study conducted in 7 pediatric gastroenterology divisions.
Patients and methods: : Children 4 to 18 years of age, meeting eligibility criteria, were enrolled. The patients were assessed by a questionnaire for a 2-week baseline period. They were then randomized to receive either VSL#3 or a placebo for 6 weeks, with controls every 2 weeks. At the end, after a "wash-out" period of 2 weeks, each patient was switched to the other group and followed for a further 6 weeks.
Results: : A total of 59 children completed the study. Although placebo was effective in some of the parameters and in as many as half of the patients, VSL#3 was significantly superior to it (P < 0.05) in the primary endpoint, the subjective assessment of relief of symptoms; as well as in 3 of 4 secondary endpoints: abdominal pain/discomfort (P < 0.05), abdominal bloating/gassiness (P < 0.05), and family assessment of life disruption (P < 0.01). No significant difference was found (P = 0.06) in the stool pattern. No untoward adverse effect was recorded in any of the patients.
Conclusions: : VSL#3 is safe and more effective than placebo in ameliorating symptoms and improving the quality of life in children affected by IBS.
Comment in
- Does VSL#3 really improve symptoms in children with IBS?
Shulman RJ, Smith EO. Shulman RJ, et al. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):109; author reply 109. doi: 10.1097/MPG.0b013e31823df69b. J Pediatr Gastroenterol Nutr. 2012. PMID: 22064630 Free PMC article. No abstract available.
Similar articles
- Symptomatic efficacy of beidellitic montmorillonite in irritable bowel syndrome: a randomized, controlled trial.
Ducrotte P, Dapoigny M, Bonaz B, Siproudhis L. Ducrotte P, et al. Aliment Pharmacol Ther. 2005 Feb 15;21(4):435-44. doi: 10.1111/j.1365-2036.2005.02330.x. Aliment Pharmacol Ther. 2005. PMID: 15709995 Clinical Trial. - A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating.
Kim HJ, Vazquez Roque MI, Camilleri M, Stephens D, Burton DD, Baxter K, Thomforde G, Zinsmeister AR. Kim HJ, et al. Neurogastroenterol Motil. 2005 Oct;17(5):687-96. doi: 10.1111/j.1365-2982.2005.00695.x. Neurogastroenterol Motil. 2005. PMID: 16185307 Clinical Trial. - The effect of a multispecies probiotic mixture on the symptoms and fecal microbiota in diarrhea-dominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial.
Ki Cha B, Mun Jung S, Hwan Choi C, Song ID, Woong Lee H, Joon Kim H, Hyuk J, Kyung Chang S, Kim K, Chung WS, Seo JG. Ki Cha B, et al. J Clin Gastroenterol. 2012 Mar;46(3):220-7. doi: 10.1097/MCG.0b013e31823712b1. J Clin Gastroenterol. 2012. PMID: 22157240 Clinical Trial. - The rationale and clinical effectiveness of probiotics in irritable bowel syndrome.
Ringel Y, Ringel-Kulka T. Ringel Y, et al. J Clin Gastroenterol. 2011 Nov;45 Suppl:S145-8. doi: 10.1097/MCG.0b013e31822d32d3. J Clin Gastroenterol. 2011. PMID: 21992954 Review. - Peppermint oil in irritable bowel syndrome.
Grigoleit HG, Grigoleit P. Grigoleit HG, et al. Phytomedicine. 2005 Aug;12(8):601-6. doi: 10.1016/j.phymed.2004.10.005. Phytomedicine. 2005. PMID: 16121521 Review.
Cited by
- The Gut Microbiota and Chronic Pain.
Pak R, Cho M, Pride K, Abd-Elsayed A. Pak R, et al. Curr Pain Headache Rep. 2024 Apr;28(4):259-269. doi: 10.1007/s11916-024-01221-x. Epub 2024 Feb 12. Curr Pain Headache Rep. 2024. PMID: 38345694 Review. - Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial.
Baldassarre ME, Di Mauro A, Mastromarino P, Fanelli M, Martinelli D, Urbano F, Capobianco D, Laforgia N. Baldassarre ME, et al. Nutrients. 2016 Oct 27;8(11):677. doi: 10.3390/nu8110677. Nutrients. 2016. PMID: 27801789 Free PMC article. Clinical Trial. - Brain-gut axis: from basic understanding to treatment of IBS and related disorders.
Camilleri M, Di Lorenzo C. Camilleri M, et al. J Pediatr Gastroenterol Nutr. 2012 Apr;54(4):446-53. doi: 10.1097/MPG.0b013e31823d34c3. J Pediatr Gastroenterol Nutr. 2012. PMID: 22027566 Free PMC article. Review. - Probiotics and irritable bowel syndrome.
Korpela R, Niittynen L. Korpela R, et al. Microb Ecol Health Dis. 2012 Jun 18;23. doi: 10.3402/mehd.v23i0.18573. eCollection 2012. Microb Ecol Health Dis. 2012. PMID: 23990830 Free PMC article. - Functional abdominal pain and irritable bowel syndrome in children and adolescents.
Chiou E, Nurko S. Chiou E, et al. Therapy. 2011 May 1;8(3):315-331. doi: 10.2217/thy.11.7. Therapy. 2011. PMID: 21731470 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources