None listed
Conditions
Brief summary
Infants born to mothers with gestational diabetes have abnormal gut bacteria, which may predispose them to adverse health outcomes such as inflammatory disorders, allergies, diabetes, obesity, neuro-developmental and neuro-behavioural impairment, cardiovascular and immune-mediated diseases. We aim to supplement these infants with probiotics to alter the bad bacteria with the hope to improve their health outcomes. Currently there are no trials in this area.
Interventions
3 billion Colony Forming Units (CFU)/ day of a combination of Bifidobacteria probiotic (1 billion CFU each of B. breve M-16V, B. longum subsp. infantis M-63 and B. longum subsp. longum BB536) given orally daily starting with first feed after birth and continued for a period of 4 months (till weaning started). Adherence to intervention will be monitored by clinical trials pharmacy by checking sachets consumed and frequency of picking up repeat prescription of the probiotic/ placebo
Sponsors
King Edward Memorial Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Days to 120 Days
Healthy volunteers
No
Inclusion criteria
gestation>35 weeks at birth Infant of mother with gestational diabetes mellitus predominantly breast feeding and intending to breast feed in future resident of Perth metropolitan area informed parental consent
Exclusion criteria
Resident outside Perth metropolitan area presence of maternal chorioamnionitis or prolonged rupture of membranes (>18 hours) babies needing antibiotics at birth mothers who have received antibiotics within 7 days prior to delivery congenital malformations chromosomal aberrations not ready for feeds due to any reason
Outcome results
None listed