Antibiotic dysbiosis and probiotics trial on infants
The aim of the ADAPTS trial is to see if probiotics can improve the health of babies that have received antibiotics early in life.
Probiotics may help to restore the changes in the gut flora that have taken place due to antibiotic use. ADAPTS is investigating whether this will help improve response to routine childhood vaccines and whether these probiotics might help to reduce gut problems such as colic.
Antibiotics are one of the most prescribed medicines in newborn infants. Exposure to antibiotics early in life causes changes to the normal gut bacteria (microflora). This may increase the risk of childhood problems such as allergic disease, asthma and obesity. Some studies have also suggested that antibiotic exposure may reduce the response to routine childhood vaccines.
Probiotics contain one or more 'friendly' bacteria that are usually part of the healthy microbial community that live inside us. Probiotics have been used widely in Australia for adults to improve their gut microflora and have been used to reduce the risk of serious gut infections in pre-term infants. However, they are not routinely used to improve the health of full-term infants, particularly those that have received antibiotics.
This study is one of the first studies to look at using probiotics in full-term newborn infants that have received antibiotics.
Who can participate?
ADAPTS is looking at full term infants less than a week old who are receiving antibiotics from the neonatal unit at Joondalup Health Campus. If an infant has a suspected or known immune deficiency or is exclusively formula fed, they are not eligible to participate.
Recruitment is now closed for this study.
What is involved in participation?
Participants will receive either placebo or probiotic drops for 28 days, when the course of antibiotics have been completed.
To see if the probiotics are effective in restoring the good bacteria in the gut, the ADAPTS team will test the infant’s stool to find out the different types and amounts of bacteria.
Infant stool samples will be collected just after stopping antibiotics and prior to starting probiotics, then again, along with a small blood sample, at 4-6 weeks, 6-8 months and 12 months. Online questionnaires will also be completed at around 1 month, 3 months and 6 months to ask about diet, use of medications, whether the infant has needed any further antibiotics and about common issues such as colic and vomiting or reflux.
ADAPTS has completed recruitment and is now in the investigation phase. The team will be soon start to analyse early participant samples. The project is expected to be completed early 2022.
The ADAPTS study is an ORIGINS sub-project and is funded by the Paul Ramsay Research Foundation.