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New treatment option for Infant, Newborn
Official title The Bloom Infant Probiotic (BIP) Study
ClinicalTrials.gov ID: NCT07189390
What this study is testing
What is Probiotic?
Probiotic is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for infant, newborn.
Also referred to as Infloran®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 28. Healthy volunteers may be eligible.
You may be able to join if
- Infants administered antibiotics in the first 28 days of life. Infants must have documented direct antibiotic exposure - defined as having received...
- 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...
You likely can't join if
- 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 treatment trial during the trial period.
See the full eligibility criteria
- 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...
- 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.
- 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 treatment trial during the trial period.
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 28 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.