Effects of a live versus heat-inactivated probiotic Bifidobacterium spp in preterm infants: a randomised clinical trial.

IF 3.9 2区 医学 Q1 PEDIATRICS
Gayatri Athalye-Jape, Meera Esvaran, Sanjay Patole, Elizabeth A Nathan, Dorota A Doherty, Edric Sim, Lakshmi Chandrasekaran, Chooi Kok, Stephan Schuster, Patricia Conway
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引用次数: 0

Abstract

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.

早产儿服用活益生菌与热灭活益生菌双歧杆菌的效果:随机临床试验。
背景:热灭活益生菌(HP)可避免活益生菌(P)的风险(如益生菌败血症),同时保留其益处,是活益生菌的有效替代品。我们对早产儿(VP:妊娠)服用益生菌的安全性和有效性进行了评估:VP 婴儿被随机分配接受益生菌或益生菌混合物(乳双歧杆菌 M-16V、长双歧杆菌亚种婴儿 M-63、长双歧杆菌亚种婴儿 BB536,总计 3×109 CFU/天),并进行盲法。主要结果是比较补充 3 周后的粪便钙蛋白(FCP)水平。次要结果包括粪便微生物群和短链脂肪酸(SCFA)水平:86名VP婴儿被随机分配到HP组或P组(各43人)。在添加辅食后的 7 天内(T1)以及第 21 至 28 天(T2),HP 组和 P 组的 FCP 和 SCFA 总含量相当。在 T2,HP 组的 FCP 中位数(范围)为 75(8-563),P 组为 80(21-277)(P=0.71)。丙酸盐在两组中均有明显提高,而丁酸盐在 HP 组中有明显提高(均为 p0.05)。Beta 多样性显示两组的群落结构相似(均 p>0.05)。在第一和第二阶段,两组的粪便放线菌、类杆菌和双歧杆菌水平变化相当。没有发生益生菌败血症:HP是安全的,与活益生菌相比,FCP无明显差异。需要进行充分的试验来评估 HP 对早产儿临床重要结果的影响:ACTRN12618000489291。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
9.00
自引率
4.50%
发文量
90
审稿时长
6-12 weeks
期刊介绍: Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.
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