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VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study.
J Pediatr Gastroenterol Nutr. 2010 Jul; 51(1):24-30.JP

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.

Authors+Show Affiliations

University of Chicago Section of Pediatric Gastroenterology, Hepatology and Nutrition, Chicago, IL, USA. sguandalini@peds.bsd.uchicago.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20453678

Citation

Guandalini, Stefano, et al. "VSL#3 Improves Symptoms in Children With Irritable Bowel Syndrome: a Multicenter, Randomized, Placebo-controlled, Double-blind, Crossover Study." Journal of Pediatric Gastroenterology and Nutrition, vol. 51, no. 1, 2010, pp. 24-30.
Guandalini S, Magazzù G, Chiaro A, et al. VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. J Pediatr Gastroenterol Nutr. 2010;51(1):24-30.
Guandalini, S., Magazzù, G., Chiaro, A., La Balestra, V., Di Nardo, G., Gopalan, S., Sibal, A., Romano, C., Canani, R. B., Lionetti, P., & Setty, M. (2010). VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. Journal of Pediatric Gastroenterology and Nutrition, 51(1), 24-30. https://doi.org/10.1097/MPG.0b013e3181ca4d95
Guandalini S, et al. VSL#3 Improves Symptoms in Children With Irritable Bowel Syndrome: a Multicenter, Randomized, Placebo-controlled, Double-blind, Crossover Study. J Pediatr Gastroenterol Nutr. 2010;51(1):24-30. PubMed PMID: 20453678.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. AU - Guandalini,Stefano, AU - Magazzù,Giuseppe, AU - Chiaro,Andrea, AU - La Balestra,Valeria, AU - Di Nardo,Giovanni, AU - Gopalan,Sarath, AU - Sibal,A, AU - Romano,Claudio, AU - Canani,Roberto Berni, AU - Lionetti,Paolo, AU - Setty,Mala, PY - 2010/5/11/entrez PY - 2010/5/11/pubmed PY - 2011/1/13/medline SP - 24 EP - 30 JF - Journal of pediatric gastroenterology and nutrition JO - J Pediatr Gastroenterol Nutr VL - 51 IS - 1 N2 - 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. SN - 1536-4801 UR - https://www.unboundmedicine.com/medline/citation/20453678/VSL L2 - https://doi.org/10.1097/MPG.0b013e3181ca4d95 DB - PRIME DP - Unbound Medicine ER -