益生菌对儿童肠胃炎时粪便分泌型免疫球蛋白 A 的调节：一项随机临床试验。
Probiotic stool secretory immunoglobulin A modulation in children with gastroenteritis: a randomized clinical trial.
机构信息
Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Department of Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Canada.
出版信息
Am J Clin Nutr. 2021 Apr 6;113(4):905-914. doi: 10.1093/ajcn/nqaa369.
BACKGROUND
We previously conducted the Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment (PROGUT) study, which identified no improvements in children with acute gastroenteritis (AGE) administered a probiotic. However, the aforementioned study did not evaluate immunomodulatory benefits.
OBJECTIVES
The object of this study was to determine if stool secretory immunoglobulin A (sIgA) concentrations in children with AGE increase more among participants administered a Lactobacillus rhamnosus/helveticus probiotic compared with those administered placebo.
METHODS
This a priori planned multicenter, randomized, double-blinded, placebo-controlled ancillary study enrolled children presenting for emergency care who received a 5-d probiotic or placebo course. Participants submitted stool specimens on days 0, 5, and 28. The primary endpoint was the change in stool sIgA concentrations on day 5 compared with baseline.
RESULTS
A total of 133 (n = 66 probiotic, 67 placebo) of 886 PROGUT participants (15.0%) provided all 3 specimens. Median stool sIgA concentrations did not differ between the probiotic and placebo groups at any of the study time points: day 0 median (IQR): 1999 (768, 4071) compared with 2198 (702, 5278) (P = 0.27, Cohen's d = 0.17); day 5: 2505 (1111, 5310) compared with 3207 (982, 7080) (P = 0.19, Cohen's d = 0.16); and day 28: 1377 (697, 2248) compared with 1779 (660, 3977) (P = 0.27, Cohen's d = 0.19), respectively. When comparing measured sIgA concentrations between days 0 and 5, we found no treatment allocation effects [β: -0.24 (-0.65, 0.18); P = 0.26] or interaction between treatment and specimen collection day [β: -0.003 (-0.09, 0.09); P = 0.95]. Although stool sIgA decreased between day 5 and day 28 within both groups (P < 0.001), there were no differences between the probiotic and placebo groups in the median changes in sIgA concentrations when comparing day 0 to day 5 median (IQR) [500 (-1135, 2362) compared with 362 (-1122, 4256); P = 0.77, Cohen's d = 0.075] and day 5 to day 28 [-1035 (-3130, 499) compared with -1260 (-4437, 843); P = 0.70, Cohen's d = 0.067], respectively.
CONCLUSIONS
We found no effect of an L. rhamnosus/helveticus probiotic, relative to placebo, on stool IgA concentrations. This trial was registered at clinicaltrials.gov as NCT01853124.
背景
我们之前进行了门诊胃肠炎益生菌治疗效果的研究（PROGUT），结果表明，给患有急性胃肠炎（AGE）的儿童服用益生菌并没有改善症状。然而，上述研究并没有评估免疫调节的益处。
目的
本研究旨在确定与安慰剂相比，给患有 AGE 的儿童服用鼠李糖乳杆菌/乳双歧杆菌益生菌是否会增加粪便分泌型免疫球蛋白 A（sIgA）的浓度。
方法
这是一项事先计划的多中心、随机、双盲、安慰剂对照的辅助研究，纳入了因急性胃肠炎就诊的儿童，他们接受了为期 5 天的益生菌或安慰剂疗程。参与者在第 0、5 和 28 天提交粪便样本。主要终点是与基线相比，第 5 天粪便 sIgA 浓度的变化。
结果
在 886 名 PROGUT 参与者（15.0%）中，共有 133 名（益生菌组 66 名，安慰剂组 67 名）提供了所有 3 个样本。在任何研究时间点，益生菌组和安慰剂组的粪便 sIgA 浓度均无差异：第 0 天中位数（IQR）：1999（768，4071）与 2198（702，5278）（P=0.27，Cohen's d=0.17）；第 5 天：2505（1111，5310）与 3207（982，7080）（P=0.19，Cohen's d=0.16）；第 28 天：1377（697，2248）与 1779（660，3977）（P=0.27，Cohen's d=0.19）。当比较第 0 天和第 5 天的测量 sIgA 浓度时，我们没有发现治疗分配效应[β：-0.24（-0.65，0.18）；P=0.26]或治疗与标本采集日之间的相互作用[β：-0.003（-0.09，0.09）；P=0.95]。尽管两组中粪便 sIgA 在第 5 天和第 28 天之间均有下降（P<0.001），但在比较第 0 天至第 5 天中位数（IQR）的 sIgA 浓度变化时，益生菌组和安慰剂组之间没有差异[500（-1135，2362）与 362（-1122，4256）；P=0.77，Cohen's d=0.075]和第 5 天至第 28 天[-1035（-3130，499）与-1260（-4437，843）；P=0.70，Cohen's d=0.067]。
结论
我们没有发现鼠李糖乳杆菌/乳双歧杆菌益生菌与安慰剂相比，对粪便 IgA 浓度有影响。这项试验在 clinicaltrials.gov 上注册为 NCT01853124。
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