Probiotics For Preventing Infectious Diarrhea in Infants
Probiotics For Preventing Infectious Diarrhea in Infants
Abstract & Commentary
Synopsis: A double-blind, placebo-controlled, randomized trial of infants fed a formula supplemented with probiotics showed a mild reduction in the days and episodes of fever, and the days and episodes of diarrhea, with no effect on respiratory tract illnesses.
Source: Weizman Z, et al. Effect of Probiotic Infant Formula on Infections in Child Care Centers: Comparison of 2 Probiotic Agents. Pediatr. 2005;115:5-9.
A double-blind, placebo-controlled, randomized trial of 201 healthy, formula-fed infants 4-10 months of age in 14 child care centers was conducted in the Beer-Sheva area of Israel. Infants were randomly assigned to receive formula supplemented with Bifidobacterium lactis, Lactobacillus reuteri, or no probiotic for 12 weeks. The concentration of microorganisms in supplemented formula, which was humanized cow’s milk formula, was 1 × 107 colony forming units per gram of formula powder, with a mean daily ingested dose of 1.2 × 109 colony forming units per day.
There were no significant differences among groups at randomization for age, birth weight, gestational age, gender, breastfeeding before the study, mean number of siblings, parental smoking, crowding (> 3 persons in a room), or presence of a household pet. There were no differences among groups during the study in the mean daily formula volume, daily number of meals, regurgitation or vomiting episodes, or adherence. There was no effect on respiratory tract illnesses. No adverse events were noted. There were no outbreaks of diarrhea during the study, and no cases of antibiotic-associated diarrhea.
Control infants had significantly more febrile episodes compared to infants fed formula supplemented with B. lactis or L. reuteri (0.41 vs 0.27 vs 0.11), more episodes of diarrhea (0.31 vs 0.13 vs 0.02), and more days of diarrhea (0.59 vs 0.37 vs 0.15). The L. reuteri group, compared to the control and B. lactis groups, had significantly fewer days with fever (0.17 vs 0.83 vs 0.86), less visits to the clinic (0.23 vs 0.55 vs 0.51), less absences from child care (0.14 vs 0.43 vs 0.41), and fewer prescriptions of antibiotics (0.06 vs 0.19 vs 0.21).
Comment by Hal B. Jenson, MD, FAAP
Probiotics, which are viable nonpathogenic bacteria, are used to colonize the intestinal tract to modify intestinal microflora and provide beneficial effects for the host. Breastfed infants normally acquire Bifidobacterium and Lactobacillus species in the first week of life. These probiotic species are regarded as safe to use clinically because they occur naturally in the intestine. Formula-fed infants have more Escherichia coli and other Gram-negative bacilli, and fewer Bifidobacterium. In this study, there was greater benefit from L. reuteri than from B. lactis. Lactobacilli are an important part of the healthy infant flora, and are probably responsible for much of colonization resistance. Lactobacilli are purported to modulate immune response, although much knowledge about the specific effects on the immune system is lacking.
There are very few randomized controlled trials of probiotics for the prevention of infections in healthy children. These results show that children who are not breastfed and who attend child care, both of which increase the risk of gastrointestinal and respiratory tract infections, may benefit from probiotic supplementation. As expected, there was no effect on respiratory tract illnesses. However, some of the statistically significant differences in this study on gastrointestinal tract infections were very minor, such as < 1 day for differences induration of fever and diarrhea, and < 1 episode of diarrhea over a 12-week period. Longer studies should accentuate the benefits. These data add to the body of evidence that probiotic therapies should not be summarily dismissed. Further studies may confirm that they provide a safe and effective means of prophylaxis for diarrhea, but questions about long-term dosing and safety, practicalities of administration, and secondary consequences would have to be addressed by longitudinal studies.
Hal B. Jenson, MD, FAAP, Chair, Department of Pediatrics, Director, Center for Pediatric Research, Eastern Virginia Medical School and Children’s Hospital of the King’s Daughters, Norfolk, VA, is Associate Editor for Infectious Disease Alert.
A double-blind, placebo-controlled, randomized trial of infants fed a formula supplemented with probiotics showed a mild reduction in the days and episodes of fever, and the days and episodes of diarrhea, with no effect on respiratory tract illnesses.Subscribe Now for Access
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