Restoring gut health of newborns- a clinical trial of probiotics

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Due to high susceptibility to infections, antibiotics are the most widely used drugs for newborns. Recent evidence suggests that antibiotics exposure in newborn period (first 4 weeks of life) predisposes to an imbalance in the gut, which may have long lasting consequences. Imbalances in the infants’ gut bacteria (microbiome) caused by antibiotics has been shown to alter the development of the neonate’s immune response. This altered immune development caused by a poorly balanced microbiome during this crucial phase of early life has been associated with the development of atopy, asthma, eczema, allergy, type 1 diabetes and inflammatory bowel disease. Mucosal immunity development in the gut has been shown to be aberrant as early as one month of age in children who go on to develop allergy symptoms in future. RESTORE is a clinical trial of a multi-strain probiotic for antibiotics exposed term newborn infants with aims to restore biodiversity and reduce dysbiosis (imbalance of bacteria) in the newborn gut in early months after birth. This is the first study of its kind to examine effects of probiotics on these high-risk infants’ gut biodiversity and mucosal immune development. Research Questions 1. Can the gut microbial diversity of infants exposed to postnatal antibiotics be restored earlier (within neonatal period after birth) by daily use of multi-strain probiotic supplementation? 2. Is this effect sustained at 3 months and 12 months? 3. Can probiotics in antibiotic exposed infants improve the production of salivary and secretory IgA to that seen in infants without antibiotics exposure? Methodology This randomised control trial will be conducted at Fiona Stanley Hospital. A total of 120 term neonates will be recruited, 80 of whom would have received antibiotics at birth for clinical reasons. Forty of the antibiotic exposed neonates will receive daily probiotics for 3 months and forty infants will receive a placebo. Forty infants without antibiotic exposure will serve as a reference group. Stool, saliva and blood will collected for microbiome and/or immunological tests at five time-points in the first 12 months of life. Predicted Benefits and Relevance: Neonatal infections, antibiotic use and allergy in later life are highly relevant health issues for infants, with gut microbiome as the potential denominator. In Australia, the economic cost of allergic diseases is estimated to be >$30 billion annually. Probiotics have been extensively used to restore microbiome balance in adults and hold potential to be useful for newborns for this indication. Although some promising data exists from animal studies, No human studies have yet determined whether probiotics are effective in rapidly restoring the balance of bacteria in term neonates’ gut following exposure to antibiotics. We are proposing a randomised control trial to determine if multi-strain probiotics can rapidly normalize the infants’ microbiome following neonatal antibiotic exposure during the crucial time of immune development and improve mucosal immunity. This study will provide insights for conducting larger multicentre trial to confirm clinical benefits; which will potentially change the practice to routinely supplement these high-risk babies with probiotics in the newborn period.

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