RecruitingACTRN12620001369910

The IMPROVE trial: IMpact of PRObiotic interVEntion in Papua New Guinean newborns.

IMpact of PRObiotic interVEntion in Papua New Guinean newborns (IMPROVE): A double-blinded randomized-controlled clinical trial to determine the feasibility and safety, and possible beneficial impact on nasopharyngeal colonization and vaccine immunity, of probiotics supplementation in Papua New Guinean newborns.

Sponsor

Telethon Kids Institute

Enrollment

195 participants

Start Date

Oct 29, 2020

Study Type

Interventional

Conditions

Clinical severe infection

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).

Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 72 Hourss

Plain Language Summary

Simplified for easier understanding

In Papua New Guinea (PNG), serious infections like blood poisoning (sepsis), pneumonia, and meningitis are leading causes of death in young children. One powerful strategy used in high-income countries to help premature newborns is giving them probiotics — beneficial live bacteria — in their first days of life. Research in India showed this reduced the risk of sepsis and lung infections. This pilot study in PNG is testing whether giving two different probiotic formulations to newborns in their first days of life is safe and feasible in this setting. It will also explore whether probiotics reduce the presence of a harmful bacteria (Streptococcus pneumoniae) in infants' noses and whether babies develop stronger immune responses to the routine pneumococcal vaccine. To be eligible, a baby must weigh at least 1.5 kg at birth, be less than 72 hours old, be feeding orally, and live within 60 minutes of the Goroka Institute of Medical Research. The baby's parents must intend to stay in the area for at least 6 months and provide consent. Babies born with suspected infection, to mothers with fever before delivery, or with major birth defects are not eligible. This is an important first step toward finding new tools to protect children's lives in PNG.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 excip

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.

Locations(1)

Goroka, Eastern Highland Province, Papua New Guinea

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12620001369910