Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.
Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.
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DOI：
10.1016/j.jpeds.2017.07.036
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发表时间：
2017-12
期刊：
影响因子：
--
通讯作者：
Rhoads JM
中科院分区：
文献类型：
--
作者：
Fatheree NY;Liu Y;Taylor CM;Hoang TK;Cai C;Rahbar MH;Hessabi M;Ferris M;McMurtry V;Wong C;Vu T;Dancsak T;Wang T;Gleason W;Bandla V;Navarro F;Tran DQ;Rhoads JM
目的：评价益生菌17938(每日给药)对健康绞痛患儿的安全性，以及LR对哭闹、炎症、免疫和微生物组变量的影响。我们对3周至3个月大的患有绞痛的健康母乳喂养婴儿进行了一项对照、双盲、I期安全性和耐受性试验，随机分配到LR组(每天5×108 CFU)或安慰剂组，为期42天，并随访134天。在117名接受筛查的婴儿中，20名被随机分配到LR或安慰剂(葵花油)(比例为2：1)，保留率为80%。20例患者中有11例(55%)中性粒细胞绝对计数较低(ANC<；1500/mm3)，所有受试者均在第176天消失。LR没有产生严重的不良事件，也没有显著改变哭泣时间、血浆碳酸氢盐或炎症生物标记物。两组患者粪便钙保护素均迅速下降。在粪便革兰氏阴性菌占主导地位的婴儿中(克雷伯氏菌、变形杆菌和韦洛氏菌)，绞痛的消退与这些微生物的显著减少有关。对于患有绞痛的新生儿，包括经常共存的中性粒细胞减少症的新生儿，每日LR似乎是安全的。66%的安慰剂反应表明，许多绞痛婴儿将在3周内得到缓解。
To assess the safety of probiotic Lactobacillus reuteri strain 17938 (with daily administration to healthy infants with colic and to determine the effect of LR on crying, fussing, inflammatory, immune and microbiome variables. We performed a controlled, double-blinded, phase I safety and tolerability trial in healthy breast-fed infants with colic aged 3 weeks to 3 months, randomly assigned to LR (5 × 108 CFUs daily) or placebo for 42 days and followed for 134 days. Of 117 screened infants, 20 were randomized to LR or placebo (sunflower oil) (in a 2:1 ratio) with 80% retention. Eleven of the 20 (55%) presented with low absolute neutrophil counts (ANC <1500 /mm3), which resolved in all subjects by day 176. LR produced no severe adverse events and did not significantly change crying time, plasma bicarbonate, or inflammatory biomarkers. Fecal calprotectin decreased rapidly in both groups. In the infants with dominant fecal gram negatives (Klebsiella, Proteus, and Veillonella), resolution of colic was associated with marked decreases in these organisms. Daily LR appears to be safe in newborn infants with colic, including those with neutropenia, which frequently co-exists. A placebo response of 66% suggests that many infants with colic will have resolution within 3 weeks.
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影响因子：
3.7
作者：
Roos S;Dicksved J;Tarasco V;Locatelli E;Ricceri F;Grandin U;Savino F
通讯作者：
Savino F
影响因子：
3.7
作者：
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DOI：
10.1152/ajpgi.00038.2014
发表时间：
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发表时间：
2006-04-01
期刊：
CLINICAL AND LABORATORY HAEMATOLOGY
影响因子：
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作者：
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通讯作者：
Özbek, N
DOI：
10.1007/s10482-015-0448-9
发表时间：
2015-06-01
影响因子：
2.6
作者：
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通讯作者：
Xu, Jin-Ke