Funders:
  • NHMRC MRFF ICTC Grant 
Primary Aim:
To determine if 7-day oral neonatal probiotics comprising a combination of Lactiplantibacillus Plantarum plus fructo-oligosaccharides (LpFOS) can reduce the risk of acute respiratory infections (ARIs) in the first year of life. 
 
Secondary Aims:

To evaluate the safety, gut microbiome and immune development after giving oral LpFOS in infants.  

 
Summary: 

The Pro-Kids trial is an international collaboration between researchers in Australia and Goroka, Papua New Guinea.  The study is a double-blind (allocation concealed), randomised controlled trial (RCT) to determine if neonatal probiotics can reduce the risk of acute respiratory infections (ARIs) in the first year of life. Eligible infants (n=148) aged less than or equal to 3 days old are eligible to participate in this clinical trial and are randomised into two groups. One group will receive the active oral probiotic treatment and the other group will receive an oral placebo for 7 consecutive days. Participants will be monitored pre and post treatment then followed up at 1-, 4- and 7-months. At the end of the study, the researchers will better understand the role of probiotics in preventing the occurrence of acute respiratory infection between birth and age 12 months. The study will also allow the researchers to evaluate the safety of probiotics, the gut microbiome and immunity development. 

 
Implications for policy and practice:
Our RCT is underpinned by high quality research and addresses a critical unmet health gap. Importantly, it leverages expertise and study power through Australian involvement in an international collaboration and is supported locally by NT hospitals, Aboriginal Medical Services (AMS) and communities. A successful intervention will change clinical practice and improve children’s lung health both immediately and into the future.
 
Chief investigator:
Project manager:
  • Dr Tejal Shah
Contact info:

For more information about the project contact, Dr Tejal Shah.

Project dates:

The project commenced in 2023 and is due for completion in 2028.

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  3. Marsh RL, Binks MJ, Smith-Vaughan HC, Janka M, Clark S, Richmond P, Chang AB, Thornton RB.  Prevalence and subtyping of biofilms present in bronchoalveolar lavage from children with protracted bacterial bronchitis or non-cystic fibrosis bronchiectasis: a cross-sectional study.  Lancet Microbe, 2022. 3(3):p.e215-e223.  DOI: 10.1016/S2666-5247(21)00300-1.
  4. Goyal V, Grimwood K, Byrnes CA, Morris PS, Masters IB, Ware RS, McCallum GB, Binks MJ, Marchant JM, van Asperen P, O'Grady KF, Champion A, Buntain HM, Petsky H, Torzillo PJ, Chang AB.  Amoxicillin-clavulanate versus azithromycin for respiratory exacerbations in children with bronchiectasis (BEST-2): a multicentre, double-blind, non-inferiority, randomised controlled trial.  Lancet, 2018. 392(10154):p.1197-1206.  DOI: 10.1016/S0140-6736(18)31723-9.
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  6. Binks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, Wilson C, Morris PS, Nelson J, Chatfield MD, Tang ML, Torzillo P, Carapetis JR, Mulholland EK, Andrews RM.  PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia.  Vaccine, 2015. 33(48):p.6579-87.  DOI: 10.1016/j.vaccine.2015.10.101.
  7. McHugh L, Marshall HS, Perrett KP, Nolan T, Wood N, Lambert SB, Richmond P, Ware RS, Binks P, Binks MJ, Andrews RM.  The Safety of Influenza and Pertussis Vaccination in Pregnancy in a Cohort of Australian Mother-Infant Pairs, 2012-2015: The FluMum Study.  Clin Infect Dis, 2019. 68(3):p.402-408.  DOI: 10.1093/cid/ciy517.
  8. Binks MJ, Smith-Vaughan HC, Marsh R, Chang AB, Andrews RM.  Cord blood vitamin D and the risk of acute lower respiratory infection in Indigenous infants in the Northern Territory.  Med J Aust, 2016. 204(6):p.238.  DOI: 10.5694/mja15.00798.
  9. Bleakley AS, Licciardi PV, Binks MJ.  Vitamin D Modulation of the Innate Immune Response to Paediatric Respiratory Pathogens Associated with Acute Lower Respiratory Infections.  Nutrients, 2021. 13(1)  DOI: 10.3390/nu13010276.
  10. McCallum GB & Binks MJ.  The Epidemiology of Chronic Suppurative Lung Disease and Bronchiectasis in Children and Adolescents.  Front Pediatr, 2017. 5:p.27.  DOI: 10.3389/fped.2017.00027.