The Bloom Infant Probiotic (BIP) Study

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

April 30, 2029

Study Completion Date

October 31, 2029

Conditions
Infant, NewbornImmunityImmunisationAntibiotic TreatmentMicrobiome Dysbiosis
Interventions
DRUG

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.

DRUG

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.

Trial Locations (2)

5006

Women's and Children's Hospital, Adelaide, Adelaide

5042

Flinders Medical Centre, Adelaide

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Flinders University

OTHER

collaborator

Women's and Children's Hospital, Adelaide

UNKNOWN

collaborator

Flinders Medical Center

UNKNOWN

collaborator

Women's & Children's Hospital Foundation

UNKNOWN

collaborator

The University of Western Australia

OTHER

lead

South Australian Health and Medical Research Institute

OTHER

NCT07189390 - The Bloom Infant Probiotic (BIP) Study | Biotech Hunter | Biotech Hunter