A placebo-controlled trial of Lactobacillus GG to prevent diarrhea in undernourished Peruvian children

Lactobacillus GG (L-GG), an acid- and bile-resistant strain that colonizes the intestinal mucosa, has been used to manage diarrhea in children. Our objective was to evaluate the prophylactic use of L-GG to prevent diarrhea in children at high risk from a developing country in a randomized, placebo-controlled trial.Two hundred four undernourished children 6 to 24 months old from an indigent peri-urban Peruvian town received either L-GG or placebo in flavored gelatin once daily, 6 days a week, for 15 months. Episodes of diarrhea were documented by daily home visits, and diagnostic studies were done in a subset of cases. Recovery of L-GG in stool from subjects and from family contacts was examined.Subjects in the L-GG group had significantly fewer episodes of diarrhea (5.21 episodes diarrhea/child/year ['ecy'] L-GG group, 6. 02 ecy placebo group; P =.028). The decreased incidence of diarrhea in the L-GG group was greatest in the 18- to 29-month age group (P =. 004) and was largely limited to nonbreastfed children (Breastfed: 6. 59 ecy L-GG, 6.32 ecy placebo, P =.7; Nonbreastfed: 4.69 ecy L-GG, 5. 86 ecy placebo, P =.005). The duration of diarrhea episodes and the causes of diarrhea were similar in both groups, except adenovirus was more common in the placebo group.L-GG supplementation may be useful as a prophylactic measure to control diarrhea in undernourished children at increased risk, especially nonbreastfed children in the toddler age group.This article features a placebo-controlled trial of Lactobacillus GG (L-GG) for diarrhea prevention in undernourished children in Peru. The purpose of the study was to evaluate the use of L-GG as prophylactic treatment for diarrhea. The study population included 204 undernourished children aged 6-24 months, 99 of which were on L-GG and 105 on placebo. Subjects were followed by daily home visits to document diarrhea episodes and diagnostic studies were conducted. Results revealed that children receiving L-GG experienced fewer episodes of diarrhea, which were more pronounced among 18-29 month old children and largely limited to non-breast-fed children. Moreover, the duration of diarrhea episodes and its causes were similar in both groups, except that adenovirus was detected more frequently in the placebo group. In conclusion, L-GG supplementation would decrease diarrhea incidence in high-risk children.