BackgroundProbiotics have rarely been studied in young healthy infants from low-income countries. This phase I study investigated the safety and acceptability of two probiotics in Bangladesh.MethodsHealthy infants aged four to twelve weeks from urban slums in Bangladesh were randomized to one of three different intervention dosing arms (daily, weekly, biweekly – once every two weeks) of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 over one month or to a fourth arm that received no probiotics. All subjects were followed for two additional months. Reported gastrointestinal and respiratory symptoms as well as breastfeeding rates, hospitalizations, differential withdrawals, and caretakers’ perception of probiotic use were compared among arms.ResultsIn total, 160 infants were randomized (40 to each arm) with 137 (Daily n = 35, Weekly n = 35, Biweekly n = 35, Control n = 32) followed up for a median of twelve weeks; 113 completed the study. Illness and breastfeeding rates were similar across all arms. Ten hospitalizations unrelated to probiotic use occurred. Forty eight percent of the caretakers of infants in intervention arms believed that probiotics improved their baby’s health.ConclusionsThese two commonly used probiotics appeared safe and well-accepted by Bangladeshi families.Trial registrationClinicalTrials.gov NCT01899378. Registered July 10, 2013.

The potential role of enteric viral infections and the developing infant virome in affecting immune responses to the oral poliovirus vaccine (OPV) is unknown. Here we performed viral metagenomic sequencing on 3 serially collected stool samples from 30 Bangladeshi infants following OPV vaccination and compared findings to stool samples from 16 age-matched infants in the United States (US). In 14 Bangladeshi infants, available post-vaccination serum samples were tested for polio-neutralizing antibodies. The abundance (p = 0.006) and richness (p = 0.013) of the eukaryotic virome increased with age and were higher than seen in age-matched US infants (p < 0.001). In contrast, phage diversity metrics remained stable and were similar to those in US infants. Non-poliovirus eukaryotic virus abundance (3.68 log10 vs. 2.25 log10, p = 0.002), particularly from potential viral pathogens (2.78log10 vs. 0.83log10, p = 0.002), and richness (p = 0.016) were inversely associated with poliovirus shedding. Following vaccination, 28.6% of 14 infants tested developed neutralizing antibodies to all three Sabin types and also exhibited higher rates of poliovirus shedding (p = 0.020). No vaccine-derived poliovirus variants were detected. These results reveal an inverse association between eukaryotic virome abundance and poliovirus shedding. Overall gut virome ecology and concurrent viral infections may impact oral vaccine responsiveness in Bangladeshi infants.

Suboptimal breastfeeding is a major cause of infant morbidity and mortality across the world. Inconsistent data has hampered quantification of this practice, however, limiting breastfeeding promotion efforts. As part of a clinical trial in Dhaka, Bangladesh, data was collected on breastfeeding patterns among 125 infants. Infants were ages 4 to 12 weeks (mean = 8.05, SD = 2.13) at the time of enrollment, and breastfeeding data were collected at 24 study visits during a twelve-week period. Breastfeeding status was assessed using the WHO-recommended “current status” (24-h recall) method. These data were used to calculate two measures: a longitudinal estimate of exclusive breastfeeding since birth and a simulated cross-sectional prevalence to approximate common data collection methods. Infants were then ranked based on their breastfeeding status at all study visits and grouped into quartiles and compared using hospitalization data recorded for all infants as part of the original study. These data showed large differences in estimates of exclusive breastfeeding behaviors when assessed longitudinally (8.8% exclusive breastfeeding) vs. calculating a cross-sectional prevalence (56.2% exclusive breastfeeding). Additionally, when infants were grouped by quartile of breastfeeding behavior and matched with hospitalization records, it was found that infants in the lowest quartile of breastfeeding behaviors were significantly more likely to be hospitalized than infants in the highest quartile. These results provide further evidence that current breastfeeding epidemiology studies may overestimate rates of exclusive breastfeeding. They also provide further evidence to support the significant infant health benefits from breastfeeding promotion.Trial registration: ClinicalTrials.gov NCT01899378. Registered July 10, 2013.

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