Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
360 participants
INTERVENTIONAL
2025-10-31
2029-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic
These participants will receive a probiotic, daily for fourteen days.
Probiotic
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.
Control
These participants will receive a placebo (contains the same excipients as the probiotic but no bacterial strains), daily for fourteen days.
Matching placebo
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.
Interventions
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Probiotic
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 placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
28 Days
ALL
Yes
Sponsors
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Flinders University
OTHER
Women's and Children's Hospital, Adelaide
UNKNOWN
Flinders Medical Center
UNKNOWN
Women's & Children's Hospital Foundation
UNKNOWN
The University of Western Australia
OTHER
South Australian Health and Medical Research Institute
OTHER
Responsible Party
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David Lynn
Professor
Locations
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Women's and Children's Hospital, Adelaide
Adelaide, South Australia, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Other Identifiers
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2025/HRE00173
Identifier Type: -
Identifier Source: org_study_id
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