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VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled,
Stefano Guandalini1, Giuseppe Magazzù, Andrea Chiaro
1University of Chicago Section of Pediatric Gastroenterology, Hepatology and Nutrition, Chicago, IL, USA. sguandalini@peds.bsd.uchicago.edu
Insights
A high-potency probiotic, VSL#3, effectively improved symptoms and quality of life for children with Irritable Bowel Syndrome (IBS). This study found VSL#3 safer and more beneficial than placebo for pediatric IBS patients.
Area of Science:
- Pediatric Gastroenterology
- Microbiome Research
- Clinical Trial Design
Background:
- Irritable Bowel Syndrome (IBS) is a prevalent pediatric condition lacking safe and effective treatments.
- Existing probiotic research for IBS has shown promise in adults, but pediatric data is limited.
- VSL#3, a specific probiotic formulation, has not been extensively studied in pediatric IBS populations.
Purpose of the Study:
- To evaluate the efficacy of VSL#3 in managing IBS symptoms in children and adolescents.
- To compare the effects of VSL#3 against a placebo in a pediatric IBS cohort.
- To assess the safety and impact on quality of life of VSL#3 treatment for pediatric IBS.
Main Methods:
- A randomized, double-blind, placebo-controlled, crossover study involving 59 children aged 4-18 with IBS.
- Participants underwent a 2-week baseline assessment followed by 6 weeks of VSL#3 or placebo, then a 2-week washout, and finally 6 weeks of the alternative treatment.
- Symptom assessment included subjective relief, abdominal pain/discomfort, bloating/gassiness, and life disruption via validated questionnaires.
Main Results:
- VSL#3 demonstrated significant superiority over placebo in subjective symptom relief (P < 0.05).
- Key secondary endpoints also showed significant improvement with VSL#3, including abdominal pain/discomfort (P < 0.05), bloating/gassiness (P < 0.05), and reduced life disruption (P < 0.01).
- No significant differences were observed in stool patterns (P = 0.06), and no adverse effects were reported.
Conclusions:
- VSL#3 is a safe and effective treatment option for pediatric Irritable Bowel Syndrome.
- VSL#3 significantly ameliorates common IBS symptoms and improves the overall quality of life in children.
- The findings support the use of VSL#3 as a therapeutic agent for managing IBS in pediatric populations.
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.
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