Related Experiment Video
Updated: Feb 12, 2026
Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Probiotics, prematurity and neurodevelopment: follow-up of a randomised trial
Susan E Jacobs1,2,3, Leah Hickey4, Susan Donath5,6
1Neonatal Services, The Royal Women's Hospital, Melbourne, Australia.
Insights
This study found that a specific probiotic combination did not negatively impact the neurodevelopment of very preterm infants. However, it did show a reduction in deafness rates among probiotic-treated children.
Area of Science:
- Neonatal care
- Developmental pediatrics
- Microbiome research
Background:
- Very preterm infants face significant risks for neurodevelopmental impairments.
- Previous research indicated that probiotics could reduce necrotizing enterocolitis in this population.
- The long-term neurodevelopmental effects of probiotics in preterm infants require further investigation.
Purpose of the Study:
- To assess the impact of a probiotic combination on the neurodevelopment of very preterm children up to 5 years corrected gestational age.
- To evaluate the safety and efficacy of probiotics in improving neurodevelopmental outcomes in this vulnerable group.
Main Methods:
- A follow-up study of survivors from a randomized controlled trial involving very preterm infants (<32 weeks gestation).
- Participants received a probiotic combination (Bifidobacterium infantis, Streptococcus thermophilus, Bifidobacterium lactis) or placebo from birth until discharge or term corrected gestational age.
- Neurodevelopmental outcomes were assessed using standardized measures up to 5 years corrected gestational age.
Main Results:
- Survival free of major neurodevelopmental impairment was similar between the probiotic and placebo groups (75.3% vs 74.9%).
- Rates of deafness were significantly lower in the probiotic group (0.6% vs 3.4%).
- No adverse effects on neurodevelopment or behavior were observed in the probiotic group.
Conclusions:
- The studied probiotic combination is safe for very preterm infants and does not adversely affect neurodevelopment.
- Probiotic administration may be associated with a reduced risk of deafness in very preterm children.
- Further research is warranted to explore the specific benefits of probiotics on sensory outcomes in preterm infants.
Objective:
To determine the impact of one probiotics combination on the neurodevelopment of very preterm children at 2-5 years corrected gestational age (CA).
Design:
Follow-up study of survivors of a double-blinded, placebo-controlled, randomised trial of probiotic effects on late-onset sepsis in very preterm infants that found reduced necrotising enterocolitis.
Setting:
10 tertiary perinatal centres in Australia and New Zealand.
Patients:
1099 very preterm infants born <32 weeks' gestation and weighing <1500 g.
Intervention:
Probiotics (Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis) or placebo administered from birth until discharge home or term CA, whichever came sooner.
Main Outcome Measures:
Major neurodevelopmental impairment comprised any of moderate/severe cerebral palsy (Gross Motor Function Classification System score 2-5), motor impairment (Bayley-III Motor Composite Scale <-2SD or Movement Assessment Battery for Children <15th centile if >42 months' CA), cognitive impairment (Bayley-III Composite Cognitive or Language Scales <-2SD or Wechsler Preschool and Primary Scale of Intelligence Full Scale Intelligence Quotient <-2SD if >42 months' CA), blindness or deafness.
Results:
Outcome data were available for 735 (67%) participants, with 71 deaths and 664/1028 survivors assessed at a mean age of 30 months. Survival free of major neurodevelopmental impairment was comparable between groups (probiotics 281 (75.3%) vs placebo 271 (74.9%); relative risk 1.01 (95% CI 0.93 to 1.09)). Rates of deafness were lower in probiotic-treated children (0.6% vs 3.4%).
Conclusion:
Administration of the probiotics combination Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis to very preterm babies from soon after birth until discharge home or term CA did not adversely affect neurodevelopment or behaviour in early childhood.
Trial Registration Number:
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN012607000144415.
Related Concept Videos
01:12Trial and Error and Algorithm
01:11Clinical Trials: Overview
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:12Statistical Software for Data Analysis and Clinical Trials
01:39Mutations
02:07Improving Translational Accuracy