[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"South Australian Health and Medical Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100607502","phase-2-the-bloom-infant-probiotic-bip-study-100607502",false,"NCT07189390","The Bloom Infant Probiotic (BIP) Study","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)","BIP","Inclusion Criteria:\n\n1. 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).\n2. Gestational age ≥ 35 weeks.\n3. Birth weight ≥ 2500g.\n4. Mother aged at least 18 years and able and willing to provide written informed consent for themselves and their infant.\n5. Parent\u002Fguardian agrees to not give any other probiotics to their infant prior to vaccination at 6 weeks, including any formula that contains probiotics.\n6. Infant planning to receive all nationally approved vaccines during next 6 months.\n\nExclusion Criteria:\n\n1. Significant medical condition in either the mother or infant that, in the opinion of a medical investigator, may interfere with the study.\n2. Infant had confirmed sepsis or other serious infection in the neonatal period.\n3. Infants with known congenital diseases or who are immunocompromised or considered medically at risk (MAR).\n4. Infant participating in another interventional trial during the trial period.",true,"ALL","28 Days",{"count":21,"type":22},360,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.\n\nAntibiotic 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.\n\nThe main questions this study aims to answer are:\n\n* 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?\n* 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?\n* 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?\n* 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?\n* 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?\n\nResearchers 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).\n\nParticipants will:\n\n* Be randomly assigned to receive either a 14-day course of probiotic Infloran® or a placebo.\n* 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.\n* Provide stool samples at four timepoints: prior to starting the intervention (probiotic\u002Fplacebo), on day 7, on day 14 after completion of the study supplement, and prior to their first vaccination at 6 weeks of age.\n* Receive routine vaccinations at 6 weeks, 4 months and 6 months in line with the National Immunisation Program\n* Complete surveys to collect information regarding probiotic\u002Fplacebo administration and vaccination related side effects\n\nThis 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.",[28,29,30,31,32],"Infant, Newborn","Immunity","Immunisation","Antibiotic Treatment","Microbiome Dysbiosis",[34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"infant","newborn","neonate","antibiotic","microbiome","microbiota","gut","probiotics","bifidobacteria","bifidobacterium","infloran","immunisation","immunity","immune system","vaccine","vaccination","immunization","randomised controlled trial","randomized controlled trial","RECRUITING","2026-05-24",{"date":56,"type":57},"2026-05-28","ACTUAL",{"date":59,"type":57},"2026-05-25",{"date":61,"type":22},"2029-10",{"name":63,"class":64},"South Australian Health and Medical Research Institute","OTHER",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":17,"sex":18,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100527458","phase-4-antibiotics-and-vaccine-immune-responses-study-100527458","NCT06148025","Antibiotics and Vaccine Immune Responses Study","A Human Experimental Medicine Study to Assess Whether the Gut Microbiota Regulates Specific and Non-specific Immune Responses to Vaccination","AVIRS","Inclusion Criteria:\n\n* 18-35 years old\n* Provided a signed and dated informed consent form\n* BCG naïve (Arm 1) and BCG and YF vaccine naïve (Arm 2)\n* Willing to take short antibiotic course\n* Willing to undergo a punch biopsy (Arm 1)\n* Willing to have up to 7 blood samples and 3 stool samples collected over 5-7 months\n* Not pregnant or intending to get pregnant for the duration of the study (a pregnancy test will be offered to females)\n\nExclusion Criteria:\n\n* Previous BCG or YF vaccination\n* Previous YF infection\n* Evidence of latent TB infection (LTBI) (assessed through a questionnaire) (IGRA to confirm if needed)\n* People with contraindications for BCG vaccination:\n\n  * malignancies involving bone marrow or lymphoid systems, primary or secondary immunodeficiencies, HIV infection\n  * moderate\u002Fsevere skin disease including eczema, dermatitis or psoriasis\n  * requiring immunosuppressive drugs or other immune modifying drugs e.g. corticosteroids, non-biological immunosuppressants, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha)\n* People with contraindications to YF vaccination:\n\n  * History of thymus disease, including myasthenia gravis, thymoma, thymectomy, DiGeorge syndrome, thymic damage from chemoradiotherapy or graft-versus-host disease\n  * YF vaccination is contraindicated in immunocompromised individuals, including individuals who have HIV infection, primary immunodeficiencies (including inherited IFNAR1 deficiency), or are taking corticosteroids or other immunosuppressive agents and haematopoietic stem cell transplant recipients\n  * People who have had a haematopoietic stem cell transplant\n  * Individuals with history of severe allergic reactions to egg or chicken proteins\n* Pregnant or breastfeeding or planning to become pregnant\n* History of renal disease\u002Finsufficiency\n* Tattoo obscuring BCG vaccination site(s)\n* Any history of severe allergic reaction or anaphylaxis to vaccination or antibiotics\n* People with chronic serious underlying illness\n* Have received any prescribed oral or intravenous antibiotic in the 28 days prior to study visits 1 and 4 (including isoniazid, rifampicin, streptomycin and ethambutol as these particular antibiotics have activity against M. bovis)","18 Years","35 Years",{"count":76,"type":22},348,[78],"PHASE4","The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination.\n\nThe main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?",[81],"Vaccine Response Impaired",[83,84,85,86,87],"Healthy participants","18-35 years old","BCG vaccine","Yellow Fever vaccine","Antibiotics","2025-12-03",{"date":90,"type":57},"2025-12-10",{"date":92,"type":57},"2023-11-23",{"date":94,"type":22},"2028-10-01",{"name":63,"class":64},1,""]