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Abstract

Background: Probiotic supplementation significantly reduces the risk of necrotising enterocolitis (NEC) and all cause mortality in preterm neonates. Independent quality assessment is important before introducing routine probiotic supplementation in this cohort.

Aim: To assess product quality, and confirm that Bifidobacterium breve (B. breve) M-16V supplementation will increase fecal B. breve counts without adverse effects.

Methods and participants: Strain identity (16S rRNA gene sequencing), viability over 2 year shelf-life were confirmed, and microbial contamination of the product was ruled out. In a controlled trial preterm neonates (Gestation <33 weeks) ready to commence or on feeds for <12 hours were randomly allocated to either B. breve M-16V (3×109 cfu/day) or placebo (dextrin) supplementation until the corrected age 37 weeks. Stool samples were collected before (S1) and after 3 weeks of supplementation (S2) for studying fecal B. breve levels using quantitative PCR (Primary outcome). Secondary outcomes included total fecal bifidobacteria and NEC≥Stage II. Categorical and continuous outcomes were analysed using Chi-square and Mann-Whitney tests, and McNemar and Wilcoxon signed-rank tests for paired comparisons.

Results: A total of 159 neonates (Probiotic: 79, Placebo: 80) were enrolled. Maternal and neonatal demographic characteristics were comparable between the groups. The proportion of neonates with detectable B. breve increased significantly post intervention: Placebo: [S1:2/66 (3%), S2: 25/66 (38%), p<0.001] Probiotic: [S1: 29/74 (40%), S2: 67/74 (91%), p<0.001]. Median S1 B. breve counts in both groups were below detection (<4.7 log cells x g(-1)), increasing significantly in S2 for the probiotic group (log 8.6) while remaining <4.7 log in the control group (p<0.001). There were no adverse effects including probiotic sepsis and no deaths. NEC≥Stage II occurred in only 1 neonate (placebo group).

Conclusion: B. breve M-16V is a suitable probiotic strain for routine use in preterm neonates.

Trial registration: Australia New Zealand Clinical Trial Registry ACTRN 12609000374268.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium breveIncreased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium breveNo Adverse Health EffectsNeutral
Large
Bifidobacterium breve Bb-03Increased Fecal Bifidobacterium breve LevelsBeneficial
Large
Bifidobacterium breve Bb-03Reduced NEC Incidence (Stage II or Greater)Beneficial
Small
Bifidobacterium breve Bb-18Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium breve BBr60Increased Fecal BifidobacteriaBeneficial
Large
Bifidobacterium breve BBr60Reduced NEC Stage II CasesBeneficial
Small
Bifidobacterium breve Bbr8Increased Fecal Bifidobacterium CountBeneficial
Large
Bifidobacterium breve Bbr8No Adverse Health EffectsNeutral
Large
Bifidobacterium breve Bbr8Reduced Occurrence of NEC (Bell's Stage 2 or Higher)Beneficial
Small
Bifidobacterium breve BR-03Increased Fecal Bifidobacterium breve LevelsBeneficial
Large
Bifidobacterium breve HA-129Increased Fecal Bifidobacterium breve LevelsBeneficial
Large
Bifidobacterium breve HA-129No Significant Increase in Adverse EffectsNeutral
Large
Bifidobacterium breve IDCC 4401Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium breve M-16VIncreased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium breve MAK40B22BIncreased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium breve MAK40B22BIncreased Fecal Bifidobacterium breve LevelsBeneficial
Large
Bifidobacterium breve MAK40B22BNo Adverse Health EffectsNeutral
Large
Bifidobacterium breve MAK40B22BReduced Incidence of NEC Stage II or GreaterBeneficial
Small
Bifidobacterium breve R0070Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium breve Rosell-70Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium breve Rosell-70No Adverse Health EffectsNeutral
Large
Bifidobacterium breve Rosell-70Reduced NEC Stage II CasesBeneficial
Small
Bifidobacterium breve SD5206Increased Fecal Bifidobacterium breve LevelsBeneficial
Large
Bifidobacterium breve SD5206No Adverse Health EffectsNeutral
Large
Bifidobacterium breve SD5206Reduced Incidence of NEC Stage II or GreaterBeneficial
Small
Bifidobacterium breve VPro 52Increased Fecal Bifidobacteria LevelsBeneficial
Large
Bifidobacterium breve VPro 52Prevention of NEC Stage IIBeneficial
Large
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