Lack of effect of Lactobacillus GG in breast-fed infants with rectal bleeding: a pilot double-blind randomized controlled trial.

OBJECTIVES

For breast-fed infants with rectal bleeding, maternal restriction of dietary protein such as cow's milk proteins is often recommended; however, poor response to dietary protein restriction is of concern. This pilot study was designed to assess the effectiveness of Lactobacillus GG (LGG) in breast-fed infants with rectal bleeding.

PATIENTS AND

METHODS

Breast-fed infants <6 months of age with rectal bleeding (defined as the presence of visible specks or streaks of blood mixed with mucus in the stool in otherwise healthy infants) were enrolled in a double-blind randomized controlled trial in which they received LGG 3 x 10 colony-forming units (n = 14) or placebo (n = 15) twice daily for 4 weeks as an adjunct to cow's milk restriction in the mother's diet. Analyses were based on allocated treatment and included data from 26 infants.

RESULTS

Mean duration of rectal bleeding was similar in the LGG and control groups (17.3 +/- 10.6 vs 15.4 +/- 11 days; mean difference -1.9 (95% confidence interval [CI] -4 to 7). No difference was found in the number of infants with clinical resolution of rectal bleeding within 72 hours and no relapse afterward (2/11 vs 3/15, relative risk [RR] 0.9, 95% CI 0.2-3.9) and the number of infants with clinical resolution of rectal bleeding within 72 hours followed by relapse of symptoms (5/11 vs 5/15, RR 1.4, 95% CI 0.5-3.5). Breast-feeding cessation was not needed in any infant.

CONCLUSIONS

These results do not support the use of LGG as an adjunct to maternal cow's milk restriction in breast-fed infants with rectal bleeding.