A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain

Pediatrics. 2010 Dec;126(6):e1445-52. doi: 10.1542/peds.2010-0467. Epub 2010 Nov 15.


Objective: Our aim was to determine whether Lactobacillus rhamnosus GG (LGG) relieves symptoms in children with recurrent abdominal pain.

Patients and methods: A total of 141 children with irritable bowel syndrome (IBS) or functional pain were enrolled in 9 primary care sites and a referral center. Children entered a randomized, double-blind, placebo-controlled trial and received LGG or placebo for 8 weeks and entered follow-up for 8 weeks. The primary outcome was overall pain at the end of the intervention period. At entry and at the end of the trial, children underwent a double-sugar intestinal permeability test.

Results: Compared with baseline, LGG, but not placebo, 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). At week 12, treatment success was achieved in 48 children in the LGG group compared with 37 children in the placebo group (P < .03); 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.

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.

Trial registration: ClinicalTrials.gov NCT00876291.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Abdominal Pain / diet therapy*
  • Abdominal Pain / etiology
  • Adolescent
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Irritable Bowel Syndrome / complications*
  • Lacticaseibacillus rhamnosus*
  • Male
  • Probiotics / therapeutic use*
  • Retrospective Studies
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00876291