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.