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A Randomized Controlled Trial of Lactobacillus GG in Children With

Functional Abdominal Pain

Francavilla R et al.

Pediatrics 2010; 126; 1445-1452

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Pronutritionist’s background

• Recurrent abdominal pain affects 4-25% of school-aged children

• There is a lack of high quality evidence for the benefit of dietary manipulation in children with abdominal pain (Huertas-Ceballos 2009)

• Most data on the use of probiotics in functional disorders are derived from studies of adults with IBS

• In adult studies, probiotics relieve symptoms among IBS patients according to a recent meta-analysis, number needed to treat (NNT) being 4 (Moayyedi PT et al. 2010)

Francavilla R et al. Pediatrics 2010; 126: 1445-1452 www.pronutritionist.net

Methods• a randomized, double-blind, placebo-controlled trial

• n = 141 children– age 5-14 years with history of symptoms circa 2 years

– irritable bowel syndrome (IBS) or functional abdominal pain (FAP) according to Rome II criteria

– Dyspepsia patients were excluded

• LGG or placebo for 8 weeks, follow-up for 8 weeks

• The primary outcome was overall pain at the end of the intervention period– a combination of the self-reported visual analog scale (VAS) and

the Faces Pain Scale (FPS) was used

• At entry and at the end of the trial, children underwent intestinal permeability test– measures ability of mannitol and lactulose to permeate the

intestinal lining helps to identity possible malabsorption or increased permeability and weakness of the intestinal lining barrier

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Results (1/2)

• LGG caused a significant reduction of both frequency (p =0,01) and severity (p = 0,01) of abdominal pain

• Effect was still seen at the end of follow-up– Only in children with IBS

• At entry, 59% of the children had abnormal results from the intestinal permeability test (IPT)

• At week 12, LGG, but not placebo, resulted in a significant reduction of intestinal permeability in children with IBS (p = 0.02) – The effect was mainly seen in children with IBS

• LGG was well tolerated, and no adverse effects were reported

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Results (2/2): treatment success*

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* a decrease of at least 50% in the number of episodes and intensity of pain

n = 141 children, 8 weeks’ placebo controlled trial, 8 weeks open label follow up

Pronutritionist’s discussion

• In this rather large trial, LGG provided a placebo-subtracted benefit of circa 20 %, in other words more than 7/10 patients get pain relief on LGG while 5/10 patients get relief on placebo

• This magnitude of effect is in line with previous studies conducted with prescription drugs in IBS (Spiller 1999)

• If multi-strain probiotics have even better effect remains unknown. Previous evidence from RCT trials suggest the improved effect of multi-strain preparations (Chapman et al. 2011)

• One of the possible mechanisms accounting for pain relief is decreased small intestine hyperpermeability through tight junction integrity as took place in the recent study

• Even if some previous studies have not shown consistent results with the present study (Bausserman et al. 2005), testing probiotic in children with IBS or functional abdominal pain seems justified taken into account favourable safety profile of LGG

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