Città della Salute e della Scienza di Torino, Regina Margherita Children Hospital, Dipartimento di Scienze della Sanità Pubblica e Pediatriche, University of Turin, Piazza Polonia 94, 10126 Turin, Italy.
Department of Paediatrics, University of Genova, Largo Gerolamo Gaslini 5, 16147 Genova, Italy.
Benef Microbes. 2015;6(3):245-51. doi: 10.3920/BM2014.0090.
Infants were recruited in four centres in North-West Italy. 138 infants were assessed for eligibility, 113 ones underwent randomisation and 105 completed the study. Newborns aged less than 10 days of life, with gestational age between 37 and 42 weeks, birth weight from 2,500 to 4,300 g and normal physical examination were recruitable. Premature infants and infants affected by outcomes of perinatal hypoxia or necrotising enterocolitis have been excluded. Patients were randomly assigned to receive five drops containing Lactobacillus reuteri DSM 17938 (108 cfu) with 400 UI of vitamin D3 or only 400 UI of vitamin D3 daily. The primary endpoints concern the administration of pain relieving agents (cimetropium bromide at least three times per week or simethicone at least five times per week) from baseline to 12 weeks. Additional analyses were done on the percentage of infants that switched from an exclusive breastfeeding to a partial or exclusive formula feeding from baseline to 12 weeks. Data concerning the number of calls to the paediatricians and the number of visits at paediatricians' ambulatories due to infantile colic have been collected by paediatrician and analysed. Comparing the two groups, the relative risk was 0.04 (95% confidence interval (CI)=0.01-0.31) for cimetropium bromide, 0.24 (95% CI=0.14-0.41) for simethicone and 0.37 (95% CI=0.17-0.80) for the administration of infant formula, showing a protective action of L. reuteri. The treatment group showed a lower number of paediatric consultations related to episodes of infant colic than the control group (P<0.0001). L. reuteri DSM 17938 supplementation at the tested dosage could reduce parental discomfort due to infantile colic. The consumption of this probiotic is associated with a reduction of paediatric consultations for infantile colic, as well as use of pain relieving agents and of infant formula.
这项研究在意大利西北部的四个中心招募婴儿。对 138 名婴儿进行了资格评估，其中 113 名婴儿接受了随机分组，105 名婴儿完成了研究。研究招募的新生儿胎龄在 37 周到 42 周之间，出生体重在 2500 克至 4300 克之间，体格检查正常。排除早产儿和围产期中度缺氧或坏死性小肠结肠炎患儿。将患儿随机分为两组，一组每天接受 5 滴含有罗伊氏乳杆菌 DSM 17938（108 cfu）和 400 UI 维生素 D3，另一组仅接受 400 UI 维生素 D3。主要终点是从基线到 12 周时，评估使用止痛药物（每周至少使用 3 次西咪替丁或每周至少使用 5 次二甲硅油）的婴儿数量。还对从基线到 12 周时，从纯母乳喂养转换为部分或完全配方奶喂养的婴儿比例进行了额外分析。儿科医生收集了与婴儿绞痛相关的儿科医生咨询次数和儿科医生门诊就诊次数的数据，并进行了分析。与对照组相比，西咪替丁的相对风险为 0.04（95%置信区间（CI）=0.01-0.31），二甲硅油为 0.24（95%CI=0.14-0.41），婴儿配方奶的使用率为 0.37（95%CI=0.17-0.80），表明罗伊氏乳杆菌具有保护作用。与对照组相比，治疗组因婴儿绞痛而就诊的次数较少（P<0.0001）。在测试剂量下补充罗伊氏乳杆菌 DSM 17938 可以减轻父母因婴儿绞痛引起的不适。这种益生菌的使用与减少儿科因婴儿绞痛的就诊次数、使用止痛药物和婴儿配方奶有关。
