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The Bloom Infant Probiotic (BIP) Study

RecruitingPhase 2Ages any - 28 DaysAllSouth Australian Health and Medical Research Inst…
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In plain words

What the trial is, and whether it could suit you

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 response to routine vaccines. Antibiotic use in the first weeks of life can lower the levels of beneficial gut bacteria, such as bifidobacteria, which play a key role in immune function. As a result, infants treated with antibiotics may produce fewer antibodies after routine vaccinations, leaving them less protected against infections. The main questions this study aims to answer are: * Does treatment with the probiotic Infloran® improve the geometric mean concentrations (GMCs) of anticapsular antibodies against at least 11 serotypes included in the pneumococcal conjugate vaccine (PCV20) in serum samples collected at 6 months of age compared with placebo in infants treated with antibiotics i

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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). 2. Gestational age ≥ 35 weeks. 3. Birth weight ≥ 2500g. 4. Mother aged at least 18 years and able and willing to provide written informed consent for themselves and their infant. 5. Parent/guardian agrees to not give any other probiotics to their infant prior to vaccination at 6 weeks, including any formula that contains probiotics. 6. Infant planning to receive all nationally approved vaccines during next 6 months. Exclusion Criteria: 1. Significant medical condition in either the mother or infant that, in the opinion of a medical investigator, may interfere with the study. 2. Infant had confirmed sepsis or other serious infection in the neonatal period. 3. Infants with known congenital diseases or who are immunocompromised or considered medically at risk (MAR). 4. Infant participating in another interventional trial during the trial period.
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What it tests

  • Probiotic
  • Matching placebo
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Where

2 sites
Women's and Children's Hospital, Adelaide
Adelaide, Australia
Flinders Medical Centre
Adelaide, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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