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Results of a double-blind, placebo-controlled study do not support use of probiotics to prevent upper respiratory and gastrointestinal infections in children aged 8-14 months at enrollment, as the probiotics did not reduce infection-related child care absences.
In the study of 290 Danish infants randomly allocated to receive a placebo or a combination of Bifidobacterium animalis subsp lactis (BB-12) and Lactobacillus rhamnosus (LGG) in a dose of 109 colony-forming units of each daily for a 6-month intervention period, there were no differences in absences from child care between the two groups (1.14 days; 95% confidence interval, −0.55 to 2.82), reported Rikke Pilmann Laursen, MSc, and her associates at the University of Copenhagen (Pediatrics. 2017. doi: 10.1542/peds.2017-0735).
Infants were a mean 10 months old at baseline, and 47% were still breastfeeding. The mean age at breastfeeding discontinuation was 12 months.
In terms of the number of children with one or more episodes of an upper respiratory tract infection, the LGG and BB-12 vs. placebo odds ratio was 1.22 (95% CI, 0.74-2.00; P = .43). The number of children with one or more episodes of diarrhea in the LGG and BB-12 vs. placebo odds ratio was 1.42 (95% CI, 0.88-2.32; P = .15).
The effect of probiotics in preventing infections in preschool-aged children has been explored in several studies and recent reviews, suggesting an effect specifically on upper respiratory tract and GI infections in small children. This study diverges in that it examined the effect of a combination of probiotics on absences from child care related to those infections in infants aged 8-14 months at the time of enrollment, whereas previous studies focused on children older than 1 year.
This study was funded by Innovation Fund Denmark, the University of Copenhagen, and Chr Hansen A/S. Dr. Kim Fleischer Michaelsen and Dr. Christian Mølgaard received a grant from Chr Hansen for the current study. None of the other investigators had any relevant financial disclosures.
Any intervention that can prevent child care–associated illnesses can have economic and educational implications, as well as public health ones. However, in the Laursen et al. study, almost 47% of the infants enrolled were breastfed, as opposed to previous studies in which the children participating generally were over 1 year old.
Given the positive effects of breastfeeding in preventing infections and the high percentage of infants who were breastfed in this study, it may be harder to distinguish the effects of the probiotic supplement in the Laursen et al. study. Indirectly, this study suggests additional information on the relative value of a probiotic intervention, compared with breastfeeding and diet, is warranted, and perhaps there is another reason to encourage breastfeeding as long as possible.
Michael D. Cabana, MD, MPH, is a professor of pediatrics, epidemiology and biostatistics and a member of the faculty at the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. Daniel J. Merenstein, MD, is an associate professor of family medicine at Georgetown University, Washington. Pharmavite, Bayer, and Sanofi have provided Georgetown University with consulting funding. Both physicians, who commented in an editorial accompanying the article by Laursen et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1729), disclosed no financial relationships relevant to this article. Dr. Merenstein has been an expert witness for Proctor & Gamble while Dr. Cabana has served as a consultant for BioGaia, Nestle, Mead Johnson, and Wyeth.
Any intervention that can prevent child care–associated illnesses can have economic and educational implications, as well as public health ones. However, in the Laursen et al. study, almost 47% of the infants enrolled were breastfed, as opposed to previous studies in which the children participating generally were over 1 year old.
Given the positive effects of breastfeeding in preventing infections and the high percentage of infants who were breastfed in this study, it may be harder to distinguish the effects of the probiotic supplement in the Laursen et al. study. Indirectly, this study suggests additional information on the relative value of a probiotic intervention, compared with breastfeeding and diet, is warranted, and perhaps there is another reason to encourage breastfeeding as long as possible.
Michael D. Cabana, MD, MPH, is a professor of pediatrics, epidemiology and biostatistics and a member of the faculty at the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. Daniel J. Merenstein, MD, is an associate professor of family medicine at Georgetown University, Washington. Pharmavite, Bayer, and Sanofi have provided Georgetown University with consulting funding. Both physicians, who commented in an editorial accompanying the article by Laursen et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1729), disclosed no financial relationships relevant to this article. Dr. Merenstein has been an expert witness for Proctor & Gamble while Dr. Cabana has served as a consultant for BioGaia, Nestle, Mead Johnson, and Wyeth.
Any intervention that can prevent child care–associated illnesses can have economic and educational implications, as well as public health ones. However, in the Laursen et al. study, almost 47% of the infants enrolled were breastfed, as opposed to previous studies in which the children participating generally were over 1 year old.
Given the positive effects of breastfeeding in preventing infections and the high percentage of infants who were breastfed in this study, it may be harder to distinguish the effects of the probiotic supplement in the Laursen et al. study. Indirectly, this study suggests additional information on the relative value of a probiotic intervention, compared with breastfeeding and diet, is warranted, and perhaps there is another reason to encourage breastfeeding as long as possible.
Michael D. Cabana, MD, MPH, is a professor of pediatrics, epidemiology and biostatistics and a member of the faculty at the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. Daniel J. Merenstein, MD, is an associate professor of family medicine at Georgetown University, Washington. Pharmavite, Bayer, and Sanofi have provided Georgetown University with consulting funding. Both physicians, who commented in an editorial accompanying the article by Laursen et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1729), disclosed no financial relationships relevant to this article. Dr. Merenstein has been an expert witness for Proctor & Gamble while Dr. Cabana has served as a consultant for BioGaia, Nestle, Mead Johnson, and Wyeth.
Results of a double-blind, placebo-controlled study do not support use of probiotics to prevent upper respiratory and gastrointestinal infections in children aged 8-14 months at enrollment, as the probiotics did not reduce infection-related child care absences.
In the study of 290 Danish infants randomly allocated to receive a placebo or a combination of Bifidobacterium animalis subsp lactis (BB-12) and Lactobacillus rhamnosus (LGG) in a dose of 109 colony-forming units of each daily for a 6-month intervention period, there were no differences in absences from child care between the two groups (1.14 days; 95% confidence interval, −0.55 to 2.82), reported Rikke Pilmann Laursen, MSc, and her associates at the University of Copenhagen (Pediatrics. 2017. doi: 10.1542/peds.2017-0735).
Infants were a mean 10 months old at baseline, and 47% were still breastfeeding. The mean age at breastfeeding discontinuation was 12 months.
In terms of the number of children with one or more episodes of an upper respiratory tract infection, the LGG and BB-12 vs. placebo odds ratio was 1.22 (95% CI, 0.74-2.00; P = .43). The number of children with one or more episodes of diarrhea in the LGG and BB-12 vs. placebo odds ratio was 1.42 (95% CI, 0.88-2.32; P = .15).
The effect of probiotics in preventing infections in preschool-aged children has been explored in several studies and recent reviews, suggesting an effect specifically on upper respiratory tract and GI infections in small children. This study diverges in that it examined the effect of a combination of probiotics on absences from child care related to those infections in infants aged 8-14 months at the time of enrollment, whereas previous studies focused on children older than 1 year.
This study was funded by Innovation Fund Denmark, the University of Copenhagen, and Chr Hansen A/S. Dr. Kim Fleischer Michaelsen and Dr. Christian Mølgaard received a grant from Chr Hansen for the current study. None of the other investigators had any relevant financial disclosures.
Results of a double-blind, placebo-controlled study do not support use of probiotics to prevent upper respiratory and gastrointestinal infections in children aged 8-14 months at enrollment, as the probiotics did not reduce infection-related child care absences.
In the study of 290 Danish infants randomly allocated to receive a placebo or a combination of Bifidobacterium animalis subsp lactis (BB-12) and Lactobacillus rhamnosus (LGG) in a dose of 109 colony-forming units of each daily for a 6-month intervention period, there were no differences in absences from child care between the two groups (1.14 days; 95% confidence interval, −0.55 to 2.82), reported Rikke Pilmann Laursen, MSc, and her associates at the University of Copenhagen (Pediatrics. 2017. doi: 10.1542/peds.2017-0735).
Infants were a mean 10 months old at baseline, and 47% were still breastfeeding. The mean age at breastfeeding discontinuation was 12 months.
In terms of the number of children with one or more episodes of an upper respiratory tract infection, the LGG and BB-12 vs. placebo odds ratio was 1.22 (95% CI, 0.74-2.00; P = .43). The number of children with one or more episodes of diarrhea in the LGG and BB-12 vs. placebo odds ratio was 1.42 (95% CI, 0.88-2.32; P = .15).
The effect of probiotics in preventing infections in preschool-aged children has been explored in several studies and recent reviews, suggesting an effect specifically on upper respiratory tract and GI infections in small children. This study diverges in that it examined the effect of a combination of probiotics on absences from child care related to those infections in infants aged 8-14 months at the time of enrollment, whereas previous studies focused on children older than 1 year.
This study was funded by Innovation Fund Denmark, the University of Copenhagen, and Chr Hansen A/S. Dr. Kim Fleischer Michaelsen and Dr. Christian Mølgaard received a grant from Chr Hansen for the current study. None of the other investigators had any relevant financial disclosures.
FROM PEDIATRICS
Key clinical point:
Major finding: Intention-to-treat analysis showed no difference between the probiotics and placebo study groups.
Data source: A randomized, double-blind, placebo-controlled study of 290 infants aged 8-14 months at enrollment.
Disclosures: This study was funded by Innovation Fund Denmark, the University of Copenhagen, and Chr Hansen A/S. Dr. Kim Fleischer Michaelsen and Dr. Christian Mølgaard received a grant from Chr Hansen for the current study. None of the other investigators had any relevant financial disclosures.