None listed
Conditions
Brief summary
Background Early life exposure to antibiotics causes significant imbalance to the healthy intestinal flora (dysbiosis), and increases the risk of non-communicable childhood conditions such as allergic disease, asthma, immune function as well as vaccine responses. Probiotics have been shown to be useful in reducing dysbiosis and having a positive effect on health. Aims This novel study aims to: 1) Study the effect of antibiotic exposure in early life and subsequent imbalances to the gut flora, 2) Study the efficacy of probiotic administration on improvement in gut flora 3) Study the effect of probiotic administration on vaccine responses and gastrointestinal symptoms. Methods This will be a double blinded, randomised controlled trial that will recruit 70 term infants that have received antibiotics from the neonatal unit at Joondalup Health Campus. Thirty-five of the infants will receive a placebo and 35 will receive a probiotic (containing lactobacillus acidophilus, bifidobacterium bifidum and bifidobacterium infantis) for a total of 4 weeks. Infant stool will be collected for microbiome analysis, blood will be collected for vaccine response and a gastro-oesophageal reflux questionnaire and a behavioural chart will be completed to review gastrointestinal and colic symptoms. Outcomes The two main analyses are: 1) Microbiome diversity and composition of operation taxonomic units of the stool will be compared between the two groups at baseline, 1 week, 2 weeks, 1 month and 8 months; and 2) antigen-specific antibody levels to vaccines will be compared between the two groups at baseline and 8 months. Benefits This study will address a major child health issue, which is to explore the negative effects of antibiotic exposure in newborn infants and provide an affordable but effective intervention (probiotics) to modulate these effects. The findings from this study will have direct benefits to infants as well as provide further evidence that early life antibiotics may have long-standing consequences. The findings will be easily translated into clinical practice and will have a significant national and international impact.
Interventions
Probiotic (Lactobacillus acidophilus, Bifidobacterium bifidum (breve) and Bifidobacterium infantis): liquid formulation; suspension is medium chain oils
Dosage: 4 drops once daily (1 drop=0.38x10^9 colony forming units)
Duration: 28 days
Mode: oral
Adherence and adverse outcomes: questionnaire completed by parent; review of bottles of trial intervention
Timing: Intervention will be administered after antibiotics have been completed. The course will be completed after 1 month (i.e. prior to the
Probiotic (Lactobacillus acidophilus, Bifidobacterium bifidum (breve) and Bifidobacterium infantis): liquid formulation; suspension is medium chain oils Dosage: 4 drops once daily (1 drop=0.38x10^9 colony forming units) Duration: 28 days Mode: oral Adherence and adverse outcomes: questionnaire completed by parent; review of bottles of trial intervention Timing: Intervention will be administered after antibiotics have been completed. The course will be completed after 1 month (i.e. prior to the routine immunisation schedule). Routine immunisations commence at 2 months of age.
Sponsors
Joondalup Health Campus
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 72 Hours
Healthy volunteers
No
Inclusion criteria
1. Newborn infant born at > 37 week post menstrual age 2. Infant less than 72 hours of age 3. Admitted with suspected sepsis and commenced on intravenous antibiotics 4. Parents have intention to give childhood immunisations 5. Parents agree to use trial intervention and not provide other forms of probiotics
Exclusion criteria
1. Anticipated antibiotic exposure for more than 5 days 2. Major congenital anomaly 3. Caesarean section
Outcome results
None listed