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

2015-07-07
Pediatric research 78(4)
- Anna Pärtty
- Liisa Lehtonen
- Marko Kalliomäki
- Seppo Salminen
- Erika Isolauri

PubMed: 26151493
DOI: 10.1038/pr.2015.127

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 30
Population: Infants with colic (n = 30)
Methods: randomized, double-blind intervention employing LGG 4.5 × 10^9 cfu/d or placebo for a 4-wk study period; all families received behavioral support and allergen avoidance diet
Blinding: Double-blind
Duration: 4-wk

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.

Research Insights

Lactobacillus rhamnosus GG→Reduced Crying
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).
Effect
Beneficial
Effect size
Moderate
Dose
4.5 × 10^9 cfu/day
Lactobacillus rhamnosus GG→Reduced Crying Time
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.
Effect
Neutral
Effect size
Small
Dose
4.5 × 10^9 cfu/day