In this randomized 8 week trial Lactobacillus GG ameliorated pain significantly among pediatric IBS / functional abdominal pain patients.

1. www.pronutritionist.net
A Randomized Controlled Trial of
Lactobacillus GG in Children With
Functional Abdominal Pain
Francavilla R et al.
Pediatrics 2010; 126; 1445-1452
Page 1 Francavilla R et al. Pediatrics 2010; 126: 1445-1452

2. Page 2
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

3. 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 overallpain 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 atthe end of the trial, children underwent
intestinalpermeability 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
Page 3 Francavilla R et al. Pediatrics 2010; 126: 1445-1452 www.pronutritionist.net

4. 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
www.pronutritionist.netFrancavilla R et al. Pediatrics 2010; 126: 1445-1452Page 4

5. Results (2/2): treatment success*
www.pronutritionist.netFrancavilla R et al. Pediatrics 2010; 126: 1445-1452Page 5
* 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

6. 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
www.pronutritionist.netFrancavilla R et al. Pediatrics 2010; 126: 1445-1452Page 6

7. 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
www.pronutritionist.netFrancavilla R et al. Pediatrics 2010; 126: 1445-1452Page 6