Infant, NewbornPhase 2BIPNCT07189390
The Bloom Infant Probiotic (BIP) Study
A Phase 2 study testing Probiotic in people with Infant, Newborn and Immunity, run by South Australian Health and Medical Research Institute at 2 sites in Australia.
Trial 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 response to routine vaccines. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Immunity, Immunisation
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 2 sitesAustralia
- Study dates
- 25 May 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Women's and Children's Hospital, Adelaide
Adelaide, South Australia, 5006
- Not yet recruiting
Flinders Medical Centre
Adelaide, South Australia, 5042
About this study
Official title: A Randomised Controlled Trial to Assess if a Probiotic Intervention Leads to Enhanced Immune Responses to Vaccination in Antibiotic-treated Infants (Bloom Infant Probiotic (BIP) Study)
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.
Read more
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 in the neonatal period?
- Does treatment with the probiotic Infloran® improve the GMCs for the pneumococcal conjugate vaccine (PCV20) at 12 months of age compared with placebo in infants treated with antibiotics in the neonatal period?
- Does treatment with the probiotic Infloran® improve the GMCs of other routine childhood vaccines at 6 and 12 months of age compared with placebo in infants treated with antibiotics in the neonatal period?
- Does treatment with the probiotic Infloran® increase the proportion of infants achieving seroprotective antibody levels for pneumococcal antigens compared to placebo in infants treated with antibiotics in the neonatal period?
- What are the differences in antigen specific T cell responses, flow cytometry, blood transcriptomics, and gut microbiota composition in the probiotic (Infloran®) vs placebo groups in infants treated with antibiotics in the neonatal period?
Researchers will compare infants who receive Infloran® (a probiotic containing Bifidobacterium bifidum and Lactobacillus acidphilus) with those who receive a placebo (which contains the same excipients as Infloran® but does not contain any bacterial strains).
Participants will:
- Be randomly assigned to receive either a 14-day course of probiotic Infloran® or a placebo.
- Provide blood samples (3-5 mL) at 6 weeks, 6.5 weeks (optional blood-draw for exploratory endpoint), 6 months and 12 months of age.
- Provide stool samples at four timepoints: prior to starting the intervention (probiotic/placebo), on day 7, on day 14 after completion of the study supplement, and prior to their first vaccination at 6 weeks of age.
- Receive routine vaccinations at 6 weeks, 4 months and 6 months in line with the National Immunisation Program
- Complete surveys to collect information regarding probiotic/placebo administration and vaccination related side effects
This study aims to recruit 360 infants to assess whether this probiotic treatment following antibiotic exposure improves the immunogenicity of vaccinations. The information from this study will improve our understanding of how probiotic intervention can support optimal immune responses to vaccination in early life. The findings could potentially influence public health strategies, offering a new way to support optimal vaccine responses in antibiotic-treated infants.
- Being tested
- Probiotic, Matching placebo
- Keywords
- infant, newborn, neonate, antibiotic, microbiome, microbiota, gut, probiotics, bifidobacteria, bifidobacterium, infloran, immunisation, immunity, immune system, vaccine, vaccination, immunization, randomised controlled trial, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDrug
Also called Infloran®
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.
Matching placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | These participants will receive a probiotic, daily for fourteen days. Receives: Drug: Probiotic |
| Control | Placebo comparator | These participants will receive a placebo (contains the same excipients as the probiotic but no bacterial strains), daily for fourteen days. Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Geometric Mean Concentrations (GMCs) of anticapsular antibodies against at least 11 serotypes included in the pneumococcal conjugate vaccine (PCV20) in serum collected at 6 months in the probiotics vs placebo group.
Measured: 6 months
Secondary outcomes (3)
The GMCs for at least 11 serotypes included in pneumococcal conjugate vaccine (PCV20) as measured by serum assay at 12 months in the probiotic vs. placebo group.
Measured: 12 months
The GMCs for other vaccine antigens (e.g. diphtheria, tetanus and pertussis toxoids, Haemophilus influenzae type b polyribosylribitol phosphate, Hepatitis B surface antigen) as measured by serum assays at 6 and 12 months in both arms.
Measured: 12 months
Proportion of infants achieving seroprotective antibody levels (i.e. seroprotection) for pneumococcal antigens.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start25 May 2026
- Primary completionMay 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Australian Health and Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Flinders University, Women's and Children's Hospital, Adelaide, Flinders Medical Center, Women's & Children's Hospital Foundation, The University of Western Australia
- Responsible party
- Principal investigator, David Lynn, South Australian Health and Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189390
- Sponsor's protocol ID
- 2025/HRE00173
- Acronym
- BIP
- Status last verified
- May 2026
- First submitted
- 16 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable individual participant data, from participants who give specific consent, may be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept SAHMRI's conditions, under a collaborator agreement, for accessing: * Individual participant data that underlie the results reported in our articles after deidentification (text, tables, figures and appendices) * Study protocol, Statistical Analysis Plan, PICF Molecular data generated from this study (i.e. transcriptomic, epigenomic and metagenomic) will be labelled with a unique identification code and stored on an appropriate data repository (e.g. Gene Expression Omnibus, Sequence Read Archive) with demographic information (age and sex). No identifying participant information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Assess if a Probiotic Intervention Leads to Enhanced Immune Responses to Vaccination in Antibiotic-treated Infants (Bloom Infant Probiotic (BIP) Study)
- ClinicalTrials.gov ID
- NCT07189390
- Acronym / sponsor ID
- BIP / 2025/HRE00173
- Keywords
- infant, newborn, neonate, antibiotic, microbiome, microbiota, gut, probiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- South Australian Health and Medical Research InstituteUniversity, hospital or other
- Collaborators
- Flinders University, Women's and Children's Hospital, Adelaide, Flinders Medical Center, Women's & Children's Hospital Foundation, The University of Western Australia
- Study start
- 25 May 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in the neonatal period?
- Does treatment with the probiotic Infloran® improve the GMCs for the pneumococcal conjugate vaccine (PCV20) at 12 months of age compared with placebo in infants treated with antibiotics in the neonatal period?
- Does treatment with the probiotic Infloran® improve the GMCs of other routine childhood vaccines at 6 and 12 months of age compared with placebo in infants treated with antibiotics in the neonatal period?
- Does treatment with the probiotic Infloran® increase the proportion of infants achieving seroprotective antibody levels for pneumococcal antigens compared to placebo in infants treated with antibiotics in the neonatal period?
- What are the differences in antigen specific T cell responses, flow cytometry, blood transcriptomics, and gut microbiota composition in the probiotic (Infloran®) vs placebo groups in infants treated with antibiotics in the neonatal period?
Researchers will compare infants who receive Infloran® (a probiotic containing Bifidobacterium bifidum and Lactobacillus acidphilus) with those who receive a placebo (which contains the same excipients as Infloran® but does not contain any bacterial strains).
Participants will:
- Be randomly assigned to receive either a 14-day course of probiotic Infloran® or a placebo.
- Provide blood samples (3-5 mL) at 6 weeks, 6.5 weeks (optional blood-draw for exploratory endpoint), 6 months and 12 months of age.
- Provide stool samples at four timepoints: prior to starting the intervention (probiotic/placebo), on day 7, on day 14 after completion of the study supplement, and prior to their first vaccination at 6 weeks of age.
- Receive routine vaccinations at 6 weeks, 4 months and 6 months in line with the National Immunisation Program
- Complete surveys to collect information regarding probiotic/placebo administration and vaccination related side effects
This study aims to recruit 360 infants to assess whether this probiotic treatment following antibiotic exposure improves the immunogenicity of vaccinations. The information from this study will improve our understanding of how probiotic intervention can support optimal immune responses to vaccination in early life. The findings could potentially influence public health strategies, offering a new way to support optimal vaccine responses in antibiotic-treated infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Drug: ProbioticThese participants will receive a probiotic, daily for fourteen days. |
| Control | Placebo comparator | Drug: Matching placeboThese participants will receive a placebo (contains the same excipients as the probiotic but no bacterial strains), daily for fourteen days. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: Infloran®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 | Probiotic |
| Matching placeboPlacebo 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. | Drug | Control |
Primary outcome
The Geometric Mean Concentrations (GMCs) of anticapsular antibodies against at least 11 serotypes included in the pneumococcal conjugate vaccine (PCV20) in serum collected at 6 months in the probiotics vs placebo group.
Time frame: 6 months
3 secondary outcomes
The GMCs for at least 11 serotypes included in pneumococcal conjugate vaccine (PCV20) as measured by serum assay at 12 months in the probiotic vs. placebo group.
Time frame: 12 months
The GMCs for other vaccine antigens (e.g. diphtheria, tetanus and pertussis toxoids, Haemophilus influenzae type b polyribosylribitol phosphate, Hepatitis B surface antigen) as measured by serum assays at 6 and 12 months in both arms.
Time frame: 12 months
Proportion of infants achieving seroprotective antibody levels (i.e. seroprotection) for pneumococcal antigens.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. Non-identifiable individual participant data, from participants who give specific consent, may be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept SAHMRI's conditions, under a collaborator agreement, for accessing: * Individual participant data that underlie the results reported in our articles after deidentification (text, tables, figures and appendices) * Study protocol, Statistical Analysis Plan, PICF Molecular data generated from this study (i.e. transcriptomic, epigenomic and metagenomic) will be labelled with a unique identification code and stored on an appropriate data repository (e.g. Gene Expression Omnibus, Sequence Read Archive) with demographic information (age and sex). No identifying participant information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Infant, Newborn and Immunity, run by South Australian Health and Medical Research Institute at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Lynn (+61 881 284 053, david.lynn@sahmri.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Geometric Mean Concentrations (GMCs) of anticapsular antibodies against at least 11 serotypes included in the pneumococcal conjugate vaccine (PCV20) in serum collected at 6 months in the probiotics vs placebo group. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.