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Updated: Jun 16, 2025
Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Effects of a live versus heat-inactivated probiotic Bifidobacterium spp in preterm infants: a randomised clinical
Gayatri Athalye-Jape1,2, Meera Esvaran3, Sanjay Patole4,5
1Neonatal Directorate, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia Gayatri.Jape@health.wa.gov.au.
Insights
Heat-inactivated probiotics (HPs) are safe and as effective as live probiotics in very preterm infants. Further trials are needed to confirm effects on clinical outcomes.
Area of Science:
- Neonatal Medicine
- Microbiome Research
- Gastroenterology
Background:
- Live probiotics (P) carry risks like sepsis in vulnerable infants.
- Heat-inactivated probiotics (HPs) offer potential benefits without live risks.
- Assessing HP safety and efficacy in very preterm (VP) infants is crucial.
Purpose of the Study:
- To evaluate the safety and efficacy of HPs compared to live probiotics in VP infants.
- To compare faecal calprotectin (FCP) levels as a primary outcome.
- To analyze secondary outcomes including faecal microbiota and short-chain fatty acid (SCFA) levels.
Main Methods:
- Randomized controlled trial involving 86 VP infants (<32 weeks gestation).
- Infants received either HPs or a P mixture (Bifidobacterium strains) for 3 weeks.
- Primary outcome: FCP levels at 3 weeks; Secondary: microbiota and SCFA composition.
Main Results:
- No significant difference in FCP levels between HP and P groups at 3 weeks (p=0.71).
- Both groups showed increased propionate; HP group showed increased butyrate (p<0.01).
- Bacterial richness, diversity, and community structure were comparable between groups; no probiotic sepsis observed.
Conclusions:
- HPs are safe for VP infants and demonstrate comparable FCP levels to live probiotics.
- HPs may be a viable alternative to live probiotics, mitigating sepsis risk.
- Larger trials are required to confirm HP efficacy on clinically significant outcomes in preterm infants.
Background:
Heat-inactivated probiotics (HPs) may provide an effective alternative to live probiotics (P) by avoiding their risks (eg, probiotic sepsis) while retaining the benefits. We assessed the safety and efficacy of a HP in very preterm (VP: gestation <32 weeks) infants.
Methods:
VP infants were randomly allocated to receive a HP or P mixture (Bifidobacterium breve M-16V, Bifidobacterium longum subsp. infantis M-63, Bifidobacterium longum subsp. longum BB536, total 3×109 CFU/day) assuring blinding. Primary outcome was faecal calprotectin (FCP) levels were compared after 3 weeks of supplementation. Secondary outcomes included faecal microbiota and short chain fatty acid (SCFA) levels.
Results:
86 VP infants were randomised to HP or P group (n=43 each). Total FCP and SCFA were comparable between HP and P groups within 7 days (T1) and between day 21 and 28 (T2) after supplementation. At T2, median (range) FCP was 75 (8-563) in the HP group and 80 (21-277) in the P group (p=0.71). Propionate was significantly raised in both groups, while butyrate was significantly raised in the HP group (all p<0.01). Bacterial richness and diversity increased but was comparable between HP and P (p>0.05). Beta diversity showed similar community structures in both groups (all p>0.05). Changes in faecal Actinobacteria, Bacteroidetes and Bifidobacteriacae levels were comparable in both groups at T1 and T2. There was no probiotic sepsis.
Conclusions:
HP was safe and showed no significant difference in FCP as compared with a live probiotic. Adequately powered trials are needed to assess the effects of HP on clinically significant outcomes in preterm infants.
Trial Registration Number:
ACTRN12618000489291.
