Not Yet RecruitingPhase 4ACTRN12624001387516

The Pro-Kids Study: Probiotics to prevent acute respiratory infection in First Nations infants in the Northern Territory

Neonatal probiotics to prevent early-onset acute respiratory infections (ARIs) in high-risk children: a multisite, double-blinded, randomised controlled trial (RCT)

Sponsor

Menzies School of Health Research

Enrollment

148 participants

Start Date

Dec 2, 2024

Study Type

Interventional

Conditions

Acute Respiratory Infection

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.

Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 3 Dayss

Inclusion Criteria9

Eligibility Criteria
Mother is aged >=18 years
Infant is of First Nations descent
Infant is a resident in urban Darwin or one of the approved participating communities
Mother/guardian must be able to provide written informed consent in English (with or without an interpreter)
Infant is born >=35 weeks gestation
Infant is <=3 days (or <=72 hours) post-partum
Infant birth weight is >2.0 kilograms (kgs)
Infant is feeding orally

Exclusion Criteria8

Infant has major congenital anomalies
Infant has known infection or signs of active infection (fever >38°C)
Infant is requiring respiratory support (except O2)
Infant is being given antibiotics <=3 days post-partum and is not suitable to enter the study in the opinion of their attending clinician
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
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
Infant is enrolled in other concurrent intervention trials deemed to conflict the outcome of this trial
Infant is on oral probiotics

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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 150

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.