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VSL#3 Improves Symptoms in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Crossover Study

Guandalini, Stefano*; Magazzù, Giuseppe; Chiaro, Andrea; La Balestra, Valeria; Di Nardo, Giovanni; Gopalan, Sarath§; Sibal, A§; Romano, Claudio||; Canani, Roberto Berni; Lionetti, Paolo#; Setty, Mala*

Journal of Pediatric Gastroenterology & Nutrition:
doi: 10.1097/MPG.0b013e3181ca4d95
Original Articles: Gastroenterology

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.

Author Information

*University of Chicago Section of Pediatric Gastroenterology, Hepatology and Nutrition, Chicago, IL, USA

Pediatric Gastroenterology Unit, University of Messina, Messina, USA

University of Rome “La Sapienza,” Rome, Italy

§CRNSS, New Delhi, India

||Pediatric Endoscopy Unit, University of Messina, Messina, USA

Department of Pediatrics, University “Federico II,” Naples

#Department of Pediatrics, University of Florence, Florence, Italy.

Received 29 June, 2009

Accepted 20 October, 2009

Address correspondence and reprint requests to Stefano Guandalini, MD, Professor of Pediatrics, University of Chicago Section of Pediatric Gastroenterology, Hepatology and Nutrition, 5839 S. Maryland Ave, MC 4065, Chicago, IL 60637 (e-mail:

This study was supported by locally available grants. There was no industry support except for providing product and placebo. No extramural financial support was provided for this investigator-initiated study.

The authors report no conflicts of interest.

Copyright 2010 by ESPGHAN and NASPGHAN