BACKGROUND The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics. AIMS To assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probiotic Bifidobacterium animalis subsp. lactis BB-12® (BB-12). Secondary outcomes were daily number of crying episodes, sleeping time, number of bowel movements and stool consistency. METHODS Randomized controlled trial (RCT) on otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive BB-12 (1 × 109 CFU/day) or placebo for 28 days. Gut microbiota structure and butyrate, beta-defensin-2 (HBD-2), cathelicidin (LL-37), secretory IgA (sIgA) and faecal calprotectin levels were assessed. RESULTS Eighty infants were randomised, 40/group. The rate of infants with reduction of ≥50% of mean daily crying duration was higher in infants treated with BB-12, starting from the end of 2nd week. No infant relapsed when treatment was stopped. The mean number of crying episodes decreased in both groups, but with a higher effect in BB-12 group (-4.7 ± 3.4 vs -2.3 ± 2.2, P < 0.05). Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB-12 group; stool consistency was similar between the two groups. An increase in Bifidobacterium abundance (with significant correlation with crying time reduction), butyrate and HBD-2, LL-37, sIgA levels associated with a decrease in faecal calprotectin level were observed in the BB-12 group. CONCLUSIONS Supplementation with BB-12 is effective in managing infant colic. The effect could derive from immune and non-immune mechanisms associated with a modulation of gut microbiota structure and function.

中文翻译：

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动物双歧杆菌亚种的治疗效果。 lactis BB-12®治疗婴儿肠绞痛：一项随机、双盲、安慰剂对照试验。


背景技术婴儿肠绞痛的发病机制尚不清楚。肠道微生物群似乎参与其中，支持益生菌的潜在治疗作用。目的 评估益生菌动物双歧杆菌亚种干预 28 天后婴儿平均每日哭泣时间减少 ≥50% 的比率。乳酸BB-12® (BB-12)。次要结果是每日哭泣次数、睡眠时间、排便次数和大便稠度。方法 对患有婴儿肠绞痛的健康纯母乳喂养婴儿进行随机对照试验 (RCT)，随机分配接受 BB-12（1 × 109 CFU/天）或安慰剂组，为期 28 天。评估了肠道微生物群结构和丁酸盐、β-防御素-2 (HBD-2)、抗菌素 (LL-37)、分泌型 IgA (sIgA) 和粪便钙卫蛋白水平。结果 80 名婴儿被随机分组​​，每组 40 名。从第 2 周末开始，接受 BB-12 治疗的婴儿平均每日哭闹时间减少 ≥50% 的比例较高。治疗停止后，没有婴儿复发。两组的平均哭泣次数均减少，但 BB-12 组的效果更高（-4.7 ± 3.4 vs -2.3 ± 2.2，P < 0.05）。两组的平均每日排便次数均有所下降，但 BB-12 组的效果显着更高；两组之间的粪便稠度相似。在 BB-12 组中观察到双歧杆菌丰度（与哭泣时间减少显着相关）、丁酸和 HBD-2、LL-37、sIgA 水平增加，且与粪便钙卫蛋白水平降低相关。结论 补充 BB-12 可有效控制婴儿绞痛。 这种效应可能源自与肠道微生物群结构和功能调节相关的免疫和非免疫机制。