Probiotics maintain intestinal secretory immunoglobulin A levels in healthy formula-fed infants: a randomised, double-blind, placebo-controlled study

Probiotics maintain intestinal secretory immunoglobulin A levels in healthy formula-fed infants: a randomised, double-blind, placebo-controlled study
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DOI:
10.3920/bm2019.0025
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发表时间:
2019-01-01
影响因子:
5.4
通讯作者:
Ben, X.
Ben, X.
中科院分区:
医学4区
文献类型:
--
作者:
Xiao, L.;Gong, C.;Ben, X.

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配方奶喂养的婴儿更容易感染传染病,因为他们缺乏从母乳中转移过来的母体免疫因子,而他们自己的免疫系统还不成熟。鉴于适时添加益生菌可促进婴儿免疫系统发育,本研究旨在评价益生菌添加剂(婴儿双歧杆菌R0033、双歧双歧杆菌R0071和瑞士乳杆菌R0052)对婴儿胃粘膜免疫功能和消化功能的影响及安全性。健康婴儿(3.5-6个月大)随机接受益生菌配方奶粉(n=66)和安慰剂配方奶粉(n=66),每天一次,连续四周。在益生菌组,在访视2(基线;V2)和访视3(治疗结束;V3)之间,粪便分泌型免疫球蛋白A(SIgA)水平保持相似,但在安慰剂组下降。益生菌组和安慰剂组治疗后sIgA水平的变化(log(10)Delta V3-V2[95%CI])具有统计学意义(分别为23 ng/dl[-57;102]和-137 ng/dl[-212;-62],P=0.0044;ANCOVA)。虽然两组唾液SIgA水平的对数(10)Delta V3-V2[95%CI]都有所增加,但益生菌组的这一趋势比安慰剂组更明显,分别增加了123 ng/dl[9;236]和37 ng/dl[-72;147](P=0.2829;ANCOVA)。在按协议人群治疗的最后一周期间,益生菌组的每周平均每天大便数量明显高于安慰剂。两组之间的微生物区系组成或人体测量参数没有差异。没有报告严重的不良事件,所有的不良事件都是轻微的,与产品或研究无关。我们的结果显示,接受益生菌的配方奶粉喂养的婴儿在四周的治疗期结束时保持了较高的粪便SIgA水平,这表明益生菌对SIgA的产生有积极作用。这项研究证明了这种益生菌制剂在婴儿中的安全性。配方奶粉喂养的婴儿可能受益于益生菌补充剂,以维持粘膜免疫的发展。
Formula-fed infants are more susceptible to infectious diseases because they lack the maternal immune factors transferred from breast milk, while their own immune system is still immature. As timely probiotic administration was suggested to promote immune system development in formula-fed infants, this study aimed at assessing the safety and the effects of a probiotic supplement (Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052) on mucosal immune competence and digestive function in formula-fed infants. Healthy infants (3.5-6 months old) were randomised to receive either probiotic- (n=66) or placebo-supplemented (n=66) formula once a day for four weeks. In the probiotics group, faecal secretory immunoglobulin A (SIgA) levels remained similar between visit 2 (baseline; V2) and visit 3 (end-of-treatment; V3), but decreased in the placebo group. Changes in SIgA levels following treatment (log(10)Delta V3-V2 [95%CI]) between the probiotic and placebo groups were statistically significant (23 ng/dl [-57;102] and -137 ng/dl [-212;-62], respectively (P=0.0044; ANCOVA)). While log(10)Delta V3-V2 [95%CI] for salivary SIgA levels increased in both groups, this trend was more pronounced in the probiotics than in the placebo group with an increase of 123 ng/dl [9;236] and 37 ng/dL [-72;147], respectively (P=0.2829; ANCOVA). The weekly average number of stools/day was significantly higher in the probiotics group compared to placebo during the last week of treatment for the per protocol population. There was no difference in microbiota composition or anthropometric parameters between groups. No serious adverse event was reported, and all adverse events were mild and unrelated to the product or study. Our results show that formula-fed infants receiving probiotics maintained higher faecal SIgA levels at the end of the four-week treatment period, suggesting a positive effect of probiotics on SIgA production. This study demonstrates the safety of this probiotic formulation in infants. Formula-fed infants may benefit from probiotics supplementation to sustain the development of mucosal immunity.