None listed
Conditions
Brief summary
Acute respiratory infections (ARIs) are a leading cause of hospitalisation and preventable death among Aboriginal infants. The first microbes encountered by the infant gut shape systemic immune development and future susceptibility to infection. Through an international partnership, we propose a randomised controlled trial to determine if neonatal probiotics can reduce the risk of ARI in the first year of life. Eligible infants aged <=3 days will be randomised into two groups where one group will receive orally the active probiotics treatment and another group will receive a placebo for 7 consecutive days total. Participants will be followed up at 1-, 4- and 7-months besides their baseline and post intervention visits and medical-review only at 12 months. Secondary aims will evaluate safety, the gut microbiome and immune development.
Interventions
Arm 1: Interventional Group
Study product - Powder of Lactiplantibacillus plantarum plus fructo oligosaccharide (LpFOS) - [L.. Plantarum ATCC 202195 1 x 1000000000 colony forming units (CFU) plus 150mg FOS with 100 mg corn maltodextrin as excipient].
Administration of the study product:
Participants will be allocated to 7-consecutive days supervised administration of the study product. Briefly, study eligible infants will be given a single daily oral dose, commencing <=3 days of birth (<=72 ho
Arm 1: Interventional Group Study product - Powder of Lactiplantibacillus plantarum plus fructo oligosaccharide (LpFOS) - [L.. Plantarum ATCC 202195 1 x 1000000000 colony forming units (CFU) plus 150mg FOS with 100 mg corn maltodextrin as excipient]. Administration of the study product: Participants will be allocated to 7-consecutive days supervised administration of the study product. Briefly, study eligible infants will be given a single daily oral dose, commencing <=3 days of birth (<=72 hours from birth) and continuing for 7 consecutive days total. The study staff mainly comprising midwives and child health nurses will be tasked with locating/recalling participants and administering the supervised dose of the study product . The product will be prepared fresh daily by mixing with 3 ml of sterile water or breast milk if it is available.
Sponsors
Menzies School of Health Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Days to 3 Days
Healthy volunteers
Yes
Inclusion criteria
Eligibility Criteria 1. Mother is aged >=18 years 2. Infant is of First Nations descent 3. Infant is a resident in urban Darwin or one of the approved participating communities Inclusion Criteria 1. Mother/guardian must be able to provide written informed consent in English (with or without an interpreter) 2. Infant is born >=35 weeks gestation 3. Infant is <=3 days (or <=72 hours) post-partum 4. Infant birth weight is >2.0 kilograms (kgs) 5. Infant is feeding orally
Exclusion criteria
Exclusion Criteria 1. Infant has major congenital anomalies 2. Infant has known infection or signs of active infection (fever >38°C) 3. Infant is requiring respiratory support (except O2) 4. Infant is being given antibiotics <=3 days post-partum and is not suitable to enter the study in the opinion of their attending clinician 5. Infant is admitted in special care nursery <=3 days post-partum and is not suitable to enter the study in the opinion of their attending clinician 6. Infant is admitted in the paediatric ward <=3 days post-partum and is not suitable to enter the study in the opinion of their attending clinician 7. Infant is enrolled in other concurrent intervention trials deemed to conflict the outcome of this trial 8. Infant is on oral probiotics
Outcome results
None listed