None listed
Conditions
Brief summary
Sepsis (blood poisening), pneumonia (lung infection) and meningitis (inflammation of tissues surrounding the brain and spinal cord) are leading causes of death in children in Papua New Guinea (PNG). Many cases of moderate-severe pneumonia and meningitis are caused by the bacterium Streptococcus pneumonia (pneumococcus). Probiotics are live beneficial bacteria. A study in India showed that giving probiotics to newborns for one week reduced their risk for sepsis, diarrhoea and lung infections. In high-income countries probiotics are often given to newborns born premature as this significantly improves their health outcomes. With high burdens of disease in children in PNG, particularly due to pneumonia and meningitis, there is a need to explore new control strategies. This pilot study seeks to demonstrate that giving probiotics to PNG newborns is safe and feasible, and will also investigate the effects of probiotics on reducing the presence of S. pneumoniae in the infant’s nose and on the child’s ability to mount a strong immune response to the pneumococcal vaccine. The aim is to test two separate probiotic formulations relative to a control in 195 babies (65 babies per group).
Interventions
Synbiotic 1, daily dose for 7 days (starting < 72 hours after birth):
Lactobacillus plantarum ATCC 202195 (1 billion CFU) combined with 150 mg fructo-oligosaccharide (FOS) with maltodextrin as excipient.
Synbiotic 2, daily dose for 7 days (starting < 72 hours after birth):
Bifidobacterium longum subspecies infantis (Bi-26) (4.2 billion CFU) combined with human oligosaccharide (HMO) (1.2 g) with maltodextrin as excipient.
Both supplements (investigational products) are supplied as lyophilize
Synbiotic 1, daily dose for 7 days (starting < 72 hours after birth): Lactobacillus plantarum ATCC 202195 (1 billion CFU) combined with 150 mg fructo-oligosaccharide (FOS) with maltodextrin as excipient. Synbiotic 2, daily dose for 7 days (starting < 72 hours after birth): Bifidobacterium longum subspecies infantis (Bi-26) (4.2 billion CFU) combined with human oligosaccharide (HMO) (1.2 g) with maltodextrin as excipient. Both supplements (investigational products) are supplied as lyophilized products in glass vials (one vial contains a single daily dose), and are reconstituted in 3 mL of breast milk expressed by the mother shortly before administration, or in 3 mL of sterile water if the mother cannot express. The full dose (3 mL suspension) is administered orally in droplets (like the oral polio vaccine) using a sterile pipette by a research nurse. The volume administered (full dose, or volume if less than 3 mL) will be recorded. Infants will be monitored for 30 min and a repeat dose will be administered if an infant vomits within this observation period.
Sponsors
Telethon Kids Institute
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
0 to 72 Hours
Healthy volunteers
Yes
Inclusion criteria
- Birth weight of at least 1.5 kg - Postnatal age of less than 72 hours - Feeding orally - Resident within 60-minute driving distance from Institute of Medical Research, Goroka - Intention to stay in the study area for at least 6 months - Parental written informed consent
Exclusion criteria
- Mother has foul smelling amniotic fluid - Heavy meconium staining of amniotic fluid (thick with dark green particulate matter) - Mother has fever (more than 38°C) within 2 days before delivery - Infant received antibiotics - Infant shows any feature of suspected infection at the time of screening - Infant has major congenital abnormality - Mother known to be HIV positive, or unknown status
Outcome results
None listed