Status:
NOT_YET_RECRUITING
The Bloom Infant Probiotic (BIP) Study
Lead Sponsor:
South Australian Health and Medical Research Institute
Collaborating Sponsors:
Flinders University
Women's and Children's Hospital, Adelaide
Conditions:
Infant, Newborn
Immunity
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to investigate whether administering a probiotic (Infloran®) to infants who received antibiotics in the first 28 days of life can restore or enhance their immune res...
Eligibility Criteria
Inclusion
- Infants administered antibiotics in the first 28 days of life. Infants must have documented direct antibiotic exposure - defined as having received at least 36 hours of antibiotic treatment in the neonatal period (the first 28 days after birth).
- Gestational age ≥ 35 weeks.
- Birth weight ≥ 2500g.
- Mother aged at least 18 years and able and willing to provide written informed consent for themselves and their infant.
- Parent/guardian agrees to not give any other probiotics to their infant prior to vaccination at 6 weeks, including any formula that contains probiotics.
- Infant planning to receive all nationally approved vaccines during next 6 months.
Exclusion
- Significant medical condition in either the mother or infant that, in the opinion of a medical investigator, may interfere with the study.
- Infant had confirmed sepsis or other serious infection in the neonatal period.
- Infants with known congenital diseases or who are immunocompromised or considered medically at risk (MAR).
- Infant participating in another interventional trial during the trial period.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07189390
Start Date
October 1 2025
End Date
October 1 2029
Last Update
September 29 2025
Active Locations (2)
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1
Women's and Children's Hospital, Adelaide
Adelaide, South Australia, Australia, 5006
2
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042