360
Participants
Start Date
October 31, 2025
Primary Completion Date
April 30, 2029
Study Completion Date
October 31, 2029
Probiotic
Probiotic capsule contents will be dissolved in a small amount of breast milk, formula or sterile water (drinking water boiled, then cooled) and administered by the infant's parent/guardian to infants as an oral bolus dose. Probiotic Infloran® Hard capsules (Bifidobacterium bifidum \& Lactobacillus acidophilus) are a listed medicine on the Australian Register of Therapeutic Goods (ARTG). Infloran® has been previously used in infants including pre-term infants for other indications including supporting healthy digestion or improving digestive system flora. Infloran® is manufactured by Laboratorio Farmaceutico SIT S.r.l., Via Cavour 70 - 27035 Mede (PV) Italy.
Matching placebo
Placebo contains the same excipients as Infloran, it is also made from the same capsule, but it does not contain any bacterial strains. Placebo capsule contents will be dissolved in a small amount of breast milk, formula or sterile water (drinking water boiled, then cooled) and administered by the infant's parent/guardian to infants as an oral bolus dose. The placebo is manufactured by Syntro Health, 558-562 Swan St, Richmond, VIC 3121.
Women's and Children's Hospital, Adelaide, Adelaide
Flinders Medical Centre, Adelaide
Collaborators (1)
Flinders University
OTHER
Women's and Children's Hospital, Adelaide
UNKNOWN
Flinders Medical Center
UNKNOWN
Women's & Children's Hospital Foundation
UNKNOWN
The University of Western Australia
OTHER
South Australian Health and Medical Research Institute
OTHER