Bloom Infant Probiotic: Can a probiotic help vaccines work better after early antibiotics?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial examines whether the probiotic Infloran® can improve antibody levels after routine vaccination in infants exposed to antibiotics soon after birth. Eligible babies are full-term or near-term (≥35 weeks) with birth weight ≥2500 g who received at least 36 hours of antibiotics in the neonatal period. Participants will be randomized to receive the probiotic or a matching placebo and immune response will be measured by anticapsular antibody GMCs against PCV20 serotypes at 6 months. The study uses standard vaccination schedules and compares antibody responses between groups to see if the probiotic supports better immune protection. Safety monitoring and follow-up are conducted as part of routine pediatric care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Women's and Children's Hospital, Adelaide
  Adelaide, South Australia, Australia Recruiting
• Flinders Medical Centre
  Adelaide, South Australia, Australia Not yet recruiting

Study contacts

• Study coordinator: David Lynn
• Email: david.lynn@sahmri.com
• Phone: +61 881 284 053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.