Smilowitz Jennifer T, Moya Jackelyn, Breck Melissa A, Cook Chelsea, Fineberg Annette, Angkustsiri Kathleen, Underwood Mark A
Department of Food Science and Technology, University of California, Davis, CA, USA.
Foods for Health Institute, University of California, One Shields Ave, Davis, CA, 95616, USA.
BMC Pediatr. 2017 May 30;17(1):133. doi: 10.1186/s12887-017-0886-9.
Historically, bifidobacteria were the dominant intestinal bacteria in breastfed infants. Still abundant in infants in developing nations, levels of intestinal bifidobacteria are low among infants in developed nations. Recent studies have described an intimate relationship between human milk and a specific subspecies of Bifidobacterium, B. longum subsp. infantis (B. infantis), yet supplementation of breastfed, healthy, term infants with this organism, has not been reported. The IMPRINT Study, a Phase I clinical trial, was initiated to determine the safety and tolerability of supplementing breastfed infants with B. infantis (EVC001).
Eighty mother-infant dyads were enrolled in either lactation support plus B. infantis supplementation (BiLS) or lactation support alone (LS). Starting with Day 7 postnatal, BiLS infants were fed 1.8-2.8 × 10 CFU B. infantis EVC001 daily in breast milk for 21 days. Mothers collected fecal samples, filled out health questionnaires, and kept daily logs about their infants' feeding and gastrointestinal symptoms from birth until Day 61 postnatal. Safety and tolerability were determined from maternal reports.
There were no differences in the mean gestational age at birth, weight 1 and 2 months postnatal, and breast milk intake between groups. The mean Log change in fecal Bifidobacterium from Day 6 to Day 28 was higher (p = 0.0002) for BiLS (6.6 ± 2.8 SD) than for LS infants (3.5 ± 3.5 SD). Daily stool number was higher (p < 0.005) for LS and lower (p < 0.05) for BiLS infants during supplementation than at Baseline. During supplementation, watery stools decreased and soft stools increased by 36% over baseline in BiLS infants (p < 0.05) with no significant changes in stool consistency for the LS infants. None of the safety and tolerability endpoints, including flatulence, bloody stool, body temperature, ratings of gastrointestinal symptoms, use of antibiotics or gas-relieving medications, infant colic, jaundice, number of illnesses, sick doctor visits, or diagnoses of eczema were different for the groups at any point.
The B. infantis EVC001 supplement was safely consumed and well-tolerated. Stools were fewer and better formed in infants in the BiLS group compared with LS group. Adverse events were those expected in healthy infants and not different between groups.
ClinicalTrials.gov NCT02457338 . Registered May 27, 2015.
从历史上看，双歧杆菌是母乳喂养婴儿肠道中的主要细菌。在发展中国家的婴儿中仍然大量存在，而在发达国家的婴儿中，肠道双歧杆菌水平较低。最近的研究描述了母乳与双歧杆菌的一个特定亚种——婴儿双歧杆菌（B. infantis）之间的密切关系，但尚未有关于给健康足月的母乳喂养婴儿补充这种微生物的报道。IMPRINT研究是一项I期临床试验，旨在确定给母乳喂养婴儿补充婴儿双歧杆菌（EVC001）的安全性和耐受性。
80对母婴被纳入哺乳支持加婴儿双歧杆菌补充组（BiLS）或仅哺乳支持组（LS）。从出生后第7天开始，BiLS组的婴儿每天在母乳中摄入1.8 - 2.8×10 CFU的婴儿双歧杆菌EVC001，持续21天。母亲们收集粪便样本，填写健康问卷，并记录从出生到出生后第61天婴儿的喂养和胃肠道症状的每日日志。安全性和耐受性由母亲的报告确定。
两组在出生时的平均胎龄、出生后1个月和2个月时的体重以及母乳摄入量方面没有差异。BiLS组（6.6±2.8标准差）从第6天到第28天粪便中双歧杆菌的平均对数变化高于LS组婴儿（3.5±3.5标准差）（p = 0.0002）。在补充期间，LS组婴儿的每日排便次数较高（p < 0.005），而BiLS组婴儿较低（p < 0.05）。在补充期间，BiLS组婴儿的水样便减少，软便比基线增加了36%（p < 0.05），而LS组婴儿的粪便稠度没有显著变化。在任何时间点，两组的安全性和耐受性终点，包括肠胃胀气、便血、体温、胃肠道症状评分、抗生素或缓解气体药物的使用、婴儿腹绞痛、黄疸、疾病数量、看医生次数或湿疹诊断等均无差异。
婴儿双歧杆菌EVC001补充剂食用安全且耐受性良好。与LS组相比，BiLS组婴儿的粪便次数更少且成形更好。不良事件是健康婴儿中预期会出现的，且两组之间没有差异。
ClinicalTrials.gov NCT02457338。于2015年5月27日注册。
