Lactobacillus GG may improve frequency and severity of pain in children with functional abdominal pain

Article Outline

• Question
• Design
• Setting
• Participants
• Intervention
• Outcomes
• Main Results
• Conclusions
• Commentary
• Reference
• Copyright

Francavilla R, Miniello V, Magista AM, De Canio A, Bucci N, Gagliardi F, et al. A randomized controlled trial of lactobacillus gg in children with functional abdominal pain. Pediatrics 2010;126:e1445-52.

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Question 

Among children with recurrent abdominal pain, is Lactobacillus rhamnosus GG (LGG) more likely to relieve symptoms than placebo?

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Design 

Randomized, double-blind, placebo-controlled trial.

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Setting 

9 primary care sites and a referral center in Italy.

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Participants 

141 children with irritable bowel syndrome (IBS) or functional pain.

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Intervention 

LGG (3x10⁹ colony forming units) or placebo twice daily for 8 weeks; patients were then monitored in follow-up for 8 weeks.

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Outcomes 

Overall pain (frequency and severity) at the end of the intervention period, as measured on a Visual Analog Scale.

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Main Results 

Compared with baseline, LGG caused a significant reduction of both frequency (P < .01) and severity (P < .01) of abdominal pain. These differences still were significant at the end of follow-up (P < .02 and P < .001, respectively). These differences were not seen for placebo. At week 12, treatment success was achieved in 48 children in the LGG group compared with 37 children in the placebo group (P < .03, Number Needed to Treat = 6); this difference still was present at the end of follow-up (P < .03). At entry, 59% of the children had abnormal results from the intestinal permeability test; LGG, but not placebo, determined a significant decrease in the number of patients with abnormal results from the intestinal permeability testing (P < .03). These effects mainly were in children with IBS.

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Conclusions 

LGG significantly reduces the frequency and severity of abdominal pain in children with IBS; this effect is sustained and may be secondary to improvement of the gut barrier.

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Commentary 

Functional gastrointestinal disorders (FGIDs) are common vexing problems in any pediatric practice with few good management options. This study describes the use of the probiotic LGG to treat 2 common FGIDs: functional abdominal pain and IBS.¹ A systematic review by the American College of Gastroenterology Task Force on the management of adults with IBS in 2009 concluded that Lactobacillus in single organism studies does not appear to be effective for patients with IBS but bifidobacteria and certain combinations of probiotics demonstrate some efficacy (Grade 2C evidence). Previous pediatric studies have been inconclusive or showed no benefit for probiotics for FGIDs. Nevertheless, interest in the use of probiotics remains high because they have significant benefit in the prevention of antibiotic-associated diarrhea, colic, and other conditions in children. Compared with previous pediatric studies, this study's design and sample size were superior, although we would have liked to have seen the two populations (functional abdominal pain vs IBS) separated, to better compare outcomes for these different clinical syndromes. As noted by the authors, it is possible that the observed positive effect of the treatment was temporary, given the chronic and relapsing nature of functional disorders. It should also be remembered that probiotics should not be used in patients with immunosuppression or those who have undergone recent gastrointestinal surgery because of a risk of sepsis. In summary, this study suggests that treatment with probiotics is of benefit in the management of FGID's in children. However, more extensive research in adults and previous pediatric studies have failed to demonstrate such effectiveness. Therefore, more studies are needed before this can be adopted as a standard treatment option in children. Such future studies will need to focus on one homogenous group and will need to follow subjects for a longer period of time.

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Reference 

1. American College of Gastroenterology Task Force on Irritable Bowel Syndrome, Brandt LJ, Chey WD, Foxx-Orenstein AE, Schiller LR, Schoenfeld PS, Spiegel BM, et al. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol 2009;104:S1-35.
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