Probiotic Lactobacillus rhamnosus GG therapy and microbiological programming in infantile colic: a randomized, controlled trial

Pediatr Res. 2015 Oct;78(4):470-5. doi: 10.1038/pr.2015.127. Epub 2015 Jul 7.


Background: Probiotic Lactobacillus reuteri and reduced allergen load may lessen the daily crying of colic infants, but the role of Lactobacillus rhamnosus GG (LGG) has remained obscure.

Methods: Infants with colic (n = 30) were enrolled during the first 6 wk of life. All families received behavioral support and allergen avoidance diet: breastfeeding mothers followed cow's milk elimination diet and formula-fed infants received extensively hydrolyzed casein formula. The randomized, double-blind intervention employed of LGG 4.5 × 10(9) cfu/d or placebo for a 4-wk study period. Daily crying was recorded by diaries and parental interviews. Fecal calprotectin and gut microbiota composition by quantitative PCR were evaluated before and after the intervention.

Results: Daily crying time was comparable between the probiotic (173 min) and the placebo group (174 min; P = 0.99) at the end of the intervention according to the parental diary. However, parents reported a decrease of 68% (95% confidence interval (CI): 58-78) in daily crying in the probiotic and 49% (95% CI: 32-66) in the placebo group (P = 0.05).

Conclusion: LGG in infants treated in tandem with behavioral support and a cow's milk elimination diet did not provide additional treatment effect for diary-verified colic crying although parental report of crying suggested the probiotic intervention effective.

Trial registration: NCT00167700.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Behavior Therapy
  • Bottle Feeding
  • Breast Feeding
  • Caseins / administration & dosage
  • Colic / diagnosis
  • Colic / microbiology
  • Colic / psychology
  • Colic / therapy*
  • Combined Modality Therapy
  • Crying
  • DNA, Bacterial / genetics
  • Double-Blind Method
  • Female
  • Finland
  • Gastrointestinal Microbiome*
  • Gastrointestinal Tract / microbiology*
  • Humans
  • Infant
  • Infant Behavior
  • Infant Formula
  • Infant, Newborn
  • Interviews as Topic
  • Lactobacillus rhamnosus / genetics
  • Lactobacillus rhamnosus / growth & development*
  • Male
  • Polymerase Chain Reaction
  • Probiotics / therapeutic use*
  • Time Factors
  • Treatment Outcome


  • Caseins
  • DNA, Bacterial
  • casein hydrolysate

Associated data