VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study.
OBJECTIVE
: 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.


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.
Guandalini
Stefano
S
University of Chicago Section of Pediatric Gastroenterology, Hepatology and Nutrition, Chicago, IL, USA. sguandalini@peds.bsd.uchicago.edu
Magazzù
Giuseppe
G
Chiaro
Andrea
A
La Balestra
Valeria
V
Di Nardo
Giovanni
G
Gopalan
Sarath
S
Sibal
A
A
Romano
Claudio
C
Canani
Roberto Berni
RB
Lionetti
Paolo
P
Setty
Mala
M
D015746:Abdominal Pain / Q000188:drug therapy / Q000209:etiology; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005190:Family; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D008297:Male; D019936:Probiotics / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome