CN109963569A - 用基于氨基酸的营养组合物喂养的婴儿或幼儿中肠道微生物群组成的正常化 - Google Patents
用基于氨基酸的营养组合物喂养的婴儿或幼儿中肠道微生物群组成的正常化 Download PDFInfo
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Abstract
本发明涉及一种营养组合物,其包含难消化纤维和产乳酸细菌,用于使得用基于氨基酸的配方喂养的婴儿或幼儿中的肠道微生物群正常化。
Description
发明背景
肠道微生物群组成(微生物肠道菌群)被认为对个体的健康和幸福及其重要。已经有许多针对胃肠系统防御机制的研究工作,其可以被视为彼此共生生活以及与人体共生生活的微生物群落。
众所周知,个体食用的食物对肠道微生物群具有高度影响。此外,生活质量和位置的参数也对个体的肠道微生物群具有明显的影响,例如存在具有(或没有)高卫生标准的水、或生活在城市环境或农村环境中。
婴儿的肠道微生物群在出生时和生命的第一阶段建立起来。受到广泛接受的是,母乳喂养的婴儿在其肠道中具有相对高数量的产乳酸细菌,其中包括双歧杆菌。据信这些细菌有助于肠的进一步成熟,而且也有助于免疫系统的促进和成熟。
最近已经确定了身体功能和肠道微生物群之间的许多新的和令人兴奋的关系,包括肠道微生物群对肥胖的影响、对神经学影响以及其他影响。因此,重要的是使配方奶喂养的婴儿保持健康的肠道微生物群,该微生物群尽可能地与母乳喂养的婴儿的肠道微生物群相似。
已知与母乳喂养的婴儿相比,相对于其他细菌,用基于牛乳蛋白的配方喂养的婴儿在其肠中具有减少量的产乳酸细菌。例如,这导致粪便pH升高。在现有技术中,已将膳食纤维添加到基于牛乳蛋白的配方中。这些膳食纤维(其中包括半乳寡糖和果寡糖)具有促进产乳酸细菌肠道生长的作用。
相当多的婴儿和幼儿群体必须依赖基于氨基酸的营养组合物。例如,对食物过敏的婴儿、特别是对非IgE介导牛乳过敏的婴儿,依赖于基于氨基酸的配方。此外,具有影响氨基酸代谢的遗传性疾病的婴儿和幼儿依赖于特定的基于氨基酸的营养组合物,这种组合物可以不含不能代谢的氨基酸。
发明人现在发现:基于氨基酸的配方喂养的婴儿的肠道微生物群不同于母乳喂养的婴儿以及正常的基于牛乳的配方喂养的婴儿。这使得基于氨基酸的配方喂养的婴儿群体成为不同于基于牛乳蛋白的配方喂养婴儿的婴儿亚群。由于基于氨基酸的配方喂养的婴儿和母乳喂养的婴儿之间的差异甚至大于母乳喂养的婴儿和牛乳配方喂养的婴儿之间的差异,因此在这些患者群体中建立健康、正常的肠道微生物群很重要。
由于并非所有膳食纤维都促进产乳酸细菌的生长,并且并非所有产乳酸细菌都能够使膳食纤维发酵,本发明人假设向可发酵的膳食纤维中添加合适的产乳酸细菌可以促进以基于氨基酸的营养物喂养患者的肠道微生物群的正常化。
发明内容
本发明人惊讶地发现:基于氨基酸配方喂养的婴儿和幼儿的肠道微生物组成(肠道菌群或肠道微生物群)不同于基于牛乳的婴儿配方喂养的婴儿以及母乳喂养的婴儿的肠道微生物群。迄今未知且无法预测,基于氨基酸配方喂养的婴儿是否会具有与蛋白质喂养的婴儿不同的肠道微生物群,如果是这样,那么肠道微生物群将如何不同。令人惊讶的是,本发明人发现,难消化纤维和产乳酸细菌的组合使该特定患者群体的肠道微生物群正常化。
因此,本发明涉及一种包含难消化纤维和产乳酸细菌的营养组合物的应用,使得用基于氨基酸的配方喂养的婴儿或幼儿中的肠道微生物群正常化。
附图说明
图1:干预开始时(t=0)和干预8周后双歧杆菌的粪便计数。在灰色弧形区域中描绘了母乳喂养婴儿的参考值。
图2:干预开始时(t=0)和干预8周后梭菌属XIVa簇(Clostridiumcluster XIVa)的粪便计数。在灰色弧形区域中描绘了母乳喂养婴儿的参考值。
具体实施方式
本发明人发现,使用基于氨基酸的配方作为蛋白质主要来源的婴儿经常发生肠道微生物群失调。典型的母乳喂养的婴儿粪便菌群的平衡在双歧杆菌中是高的,并且在成体样菌株(如梭菌属XIV簇的成员)中是低的。
在本文中,术语如“基于氨基酸的配方”、“基于氨基酸的饮食”等描述营养组合物,其中,蛋白质源包含至少70重量%的游离氨基酸,优选至少80重量%、甚至更优选至少90重量%的游离氨基酸,最优选90-100重量%的游离氨基酸。基于氨基酸的营养组合物的示例是纽康特(Neocate)和安纳米宝贝(Anamix Infant)[均为纽迪希亚医学营养公司(Nutricia Advance Medical Nutrition)]。
本发明的组合物特别适用于由基于氨基酸的组合物进行喂养的婴儿和/或幼儿。婴儿的年龄为0-12个月,幼儿的年龄为13-36个月。在根据本发明的一个实施方式中,对象是0-36个月的婴儿或幼儿。优选地,对象是0-12个月的婴儿。在下面,除非另有说明,否则在写了“婴儿”的地方,同样表示幼儿。
正常母乳喂养或牛乳喂养的儿童从蛋白质中获得大部分氨基酸,蛋白质在消化道中水解产生游离氨基酸。因此,婴儿可获得的大多数氨基酸以蛋白质的形式消耗。
由基于氨基酸的配方喂养的婴儿是在其饮食中每日消耗至少50重量%的游离氨基酸形式的氨基酸摄入量的婴儿,优选至少60、70、80、90重量%的氨基酸摄入量是游离氨基酸形式的,最优选约100重量%是游离氨基酸形式的。进一步优选地,每日氨基酸摄入量的80-100重量%是游离氨基酸形式。基于氨基酸的配方喂养的婴儿通常有避免食用蛋白质的原因。这些原因可能包括对特定蛋白质的过敏、或致使蛋白质中存在的某些氨基酸引起不良身体反应的代谢疾病。具体地,通常依赖于基于氨基酸的配方的婴儿是具有食物过敏症或氨基酸代谢疾病的婴儿。
患有过敏症的婴儿可能具有任意过敏症,但具体地,对牛乳过敏(牛乳过敏症;CMA)的婴儿依赖于基于氨基酸的婴儿配方,并且是其肠道微生物群特别受益于使用本发明组合物的婴儿。
具有氨基酸代谢疾病的婴儿通常也依赖于基于氨基酸的配方,因为蛋白质通常还包含引起不良反应的特定氨基酸。此类疾病包括苯丙酮尿症、枫糖尿症(maple syrupurine disease)、戊二酸血症(glutaric academia)和甲基丙二酸血症(methylmalonicacademia)。
发明人进一步发现(如实施例1中所示):基于氨基酸的配方喂养的婴儿的肠道微生物群不同于用基于乳蛋白的配方喂养的配方喂养婴儿。该差别很大并且使得发明人假设肠道微生物群受基于氨基酸的配方影响。与母乳喂养的婴儿相比,基于氨基酸的配方喂养的婴儿具有更低(得多)比例的产乳酸细菌,并且具有更高比例的梭菌属XIV簇的细菌成员。
由于肠道微生物群被认为对于多种健康问题(肠道成熟、免疫系统的发育、肠通透性(gut permeability)等)非常重要,本发明人开发了一种能够使肠道微生物群正常化的组合物。
在本文中使肠道微生物群正常化意味着改变肠道微生物群的组成以便更接近地类似于母乳喂养婴儿的肠道微生物群。也就是说,用基于氨基酸的配方喂养的婴儿中存在的失调得到缓解。或者换句话说,“使肠道微生物群正常化”是指对用基于氨基酸的配方奶喂养婴儿中的失调进行处理。因此,本组合物使得用基于氨基酸配方喂养的婴儿的肠道微生物群中的产乳酸细菌增多,并降低了梭菌属细菌的比例。母乳喂养的婴儿应理解为用人乳(优选来自其天然母亲的人乳)喂养的婴儿。
令人惊讶地,如实施例2所示,本发明人发现:同时给予难消化纤维和产乳酸细菌实现了对用基于氨基酸的配方喂养的婴儿中的失调进行处理。图1显示了与对照(不含难消化纤维且不含产乳酸细菌的基于氨基酸的配方)相比,用本发明组合物替代常规饮食之前(t=0)和用本发明组合物替代常规饮食之后8周的双歧杆菌百分比。在补充8周后,试验组在正常(母乳喂养、年龄相当)婴儿的双歧杆菌计数范围内,而对照组仍然表现出强烈的失调。试验组和对照组之间的差异具有统计学显著性。
在梭菌属XIV簇的细菌成员中发现了类似的令人惊讶的结果,所述梭菌属XIV簇被认为对婴儿的肠道健康具有负面影响。梭菌属XIV簇的细菌成员通常发现于更多的成人肠道菌群中,并且以较小比例存在于婴儿中。然而,与对照相比,在用本发明的组合物替代常规饮食时,试验组使细菌的梭菌属簇显著减少。因此,与年龄相当的母乳喂养的婴儿相比,微生物群正常化,对于梭菌属细菌也是如此。
难消化纤维
本组合物包含难消化纤维。在本文中,难消化纤维是指难以消化的寡糖和多糖,其不会通过人上消化道(即,小肠和胃)中存在的酸或消化酶的作用被内源人消化系统消化或仅部分被内源人消化系统消化。难消化纤维可以通过肠道微生物群的发酵作用来分解。该发酵导致形成一种或多种有机酸,优选乳酸、丁酸、丙酸和/或乙酸。
因为难消化纤维用作存在于肠道微生物群中的至少产乳酸细菌的食物来源,优先促进肠道产乳酸细菌的生长。在本文中,产乳酸细菌优选包括来自双歧杆菌属和/或乳杆菌属的微生物。在优选的实施方式中,促进双歧杆菌(Bifidobacteria)的生长,最优选促进短双歧杆菌(Bifidobacterium breve)的生长。在用基于氨基酸的配方喂养的婴儿中,较高比例的双歧杆菌和/或乳杆菌(表示为总细菌的%)促进与母乳喂养婴儿的肠道微生物群相当的正常肠道微生物群的形成,并且产生健康益处。
难消化纤维可以是(水)可溶性的或(水)不溶性难消化纤维。优选地,难消化纤维是(水)可溶性难消化纤维。在本文中,“可溶性”是指在20℃下在水中的溶解度为至少0.1g/100ml,优选至少0.5g/100ml。
本文中的难消化纤维优选为选自下组的至少一种类型、更优选至少两种类型的难消化纤维:果寡糖(包括菊粉)、半乳寡糖(包括反式半乳寡糖)、木寡糖、阿拉伯寡糖(arabino-oligosaccharide)、阿拉伯半乳寡糖(arabinogalacto-oligosaccharide)、葡萄糖寡糖(gluco-oligosaccharide)[包括环糊精、龙胆寡糖(gentio-oligosaccharide)和黑曲霉寡糖(Nigero-Oligosaccharide)和难消化的聚右旋糖]、壳寡糖、葡甘露寡糖(glucomanno-oligosaccharide)、半乳甘露寡糖(galactomanno-oligosaccharide)(包括部分水解的瓜尔胶)、甘露寡糖、岩藻黄素寡糖(fuco-oligosaccharide)、含有唾液酸的寡糖、糖醛酸寡糖(uronic acid oligosaccharide)[包括葡糖醛酸寡糖(galcturonic acidoligosaccharide)和果胶降解产物]。
优选地,根据本发明的本组合物包含难消化纤维,其导致增多的乳酸产生和/或提高产乳酸细菌的生长。难消化纤维优选选自下组:半乳寡糖、果寡糖、果多糖(fructopolysaccharide)、岩藻寡糖(fucosyloligosaccharide)、聚右旋糖、阿拉伯树胶或其衍生物、以及果胶或其衍生物。进一步优选难消化纤维选自下组:果寡糖、非牛乳衍生岩藻寡糖和聚右旋糖。
如本文所用的难消化纤维的上下文中,“寡糖”包括DP为至多10的短链寡糖以及DP大于10、优选大于25、更优选大于50的长链寡糖。DP大于10的长链寡糖也称为多糖。
在优选实施方式中,所述组合物至少包含两种不同的难消化纤维,优选短链寡糖和长链寡糖的组合。进一步优选短链寡糖和长链寡糖混合物中的重量比为25至0.05,更优选20至1。
金合欢胶(Acacia gum,GUM)或阿拉伯树胶(gum arabic)是从塞内加尔金合欢木(Acacia senegal)和塞伊耳相思树(A.seyal)的茎和枝获得的可溶性膳食纤维。其主要包含复杂多糖(95%),所述复杂多糖由高度支化的半乳聚糖聚合物组成,具有半乳糖和/或阿拉伯糖侧链,可能被鼠李糖或葡糖醛酸残基封端。
更优选地,本组合物包含果寡糖、半乳寡糖和/或半乳醛酸寡糖。在优选实施方式中,组合物包含果寡糖的混合物,其也用于实施例2。
在另一优选实施方式中,所述组合物包含短链果寡糖(“scFOS”,具有至多10的平均DP)和长链果寡糖(“lcFOS”,具有大于50的平均DP)、或菊粉(其是scFOS和lcFOS的混合物)。优选地,scFOS:lcFOS的比率为20至1,更优选9:1。
果寡糖不是源自牛乳(比如半乳寡糖),因此其非常合适用于针对牛乳过敏婴儿的基于氨基酸的配方。
优选的,所述组合物每100ml包含80mg至3g的难消化纤维,更优选150mg至2g的难消化纤维,更优选300mg至1.5g的难消化纤维。
以干重量为基准计,所述组合物优选包含0.25重量%至7.5重量%的难消化纤维(每克干重2.5-7.5mg),更优选0.5重量%至5.5重量%,更优选1.0重量%至4.0重量%,更优选1.5重量%至3.0重量%。较低量的难消化纤维在促进肠道微生物群中产乳酸细菌方面效果较差,而过量则导致副作用,例如腹胀和腹部不适。
产乳酸细菌
细菌的免疫作用是高度物种和/或菌株特异性的。因此,发明人在识别基于氨基酸的营养组合物的饮食中用作益生菌的最有效和安全的物种领域中进行了广泛的临床前工作。
本文中产乳酸细菌优选包括来自双歧杆菌(Bifidobacterium)属和/或乳杆菌(Lactobacillus)属的细菌,优选双歧杆菌,例如优选选自下组:短双歧杆菌(Bifidobacterium breve)、长双歧杆菌(Bifidobacterium longum)、婴儿双歧杆菌(Bifidobacterium infantis)和乳双歧杆菌(Bifidobacterium lactis)。最优选,产乳酸细菌是短双歧杆菌(Bifidobacterium breve)
短双歧杆菌(B.breve)是革兰氏阳性的厌氧支化杆状细菌。与短双歧杆菌ATCC15700型菌株相比,短双歧杆菌优选与16S rRNA序列具有至少95%的同一性,更优选具有至少97%的同一性(Stackebrandt&Goebel,1994,Int.J.Syst.Bacteriol 44:846-849)。优选短双歧杆菌菌株是从健康的母乳喂养的婴儿的粪便中分离的菌株。
通常,产乳酸细菌可从乳酸菌的生产商购得,但其也可直接从粪便中分离、识别、表征和生产。
根据优选的实施方式,本发明的组合物含有选自下组的至少一种短双歧杆菌:短双歧杆菌Bb-03[罗地亚公司(Rhodia)/丹尼斯克公司(Danisco)]、短双歧杆菌M-16V[森永公司(Morinaga)]、短双歧杆菌R0070(罗塞尔研究所,Lallemand)、短双歧杆菌BR03[益生菌公司(Probiotical)]、短双歧杆菌BR92[细胞生物技术(Cell Biotech)]、短双歧杆菌NCC2950(CNCM 1-3865、DSM 20091、LMG 11613、YIT4065、FERM BP-6223和CNCM 1-2219。最优选,短双歧杆菌选自下组:短双歧杆菌M-16V和短双歧杆菌CNCM 1-2219,最优选短双歧杆菌M-16V。短双歧杆菌M-16V保藏在比利时微生物菌群协调寄存中心(Belgian Co-ordinated Collections of Microorganisms,BCCM)中,并命名为LMG 23729。
优选地,本发明的组合物包含:相对于每克难消化纤维的总量,104至1012个、更优选105至1011个、最优选107至5×1010个集落形成单位(cfu)的产乳酸细菌。在另一个优选的实施方式中,产乳酸细菌的浓度为每克难消化纤维2.0x 108至2.0x 1011cfu产乳酸细菌。
相对于本发明组合物的每克干重,本发明的组合物优选含有102至1013个集落形成单位(cfu)的产乳酸细菌,优选104至1012,更优选105至1011,更优选106至1011,最优选107至1010cfu的产乳酸细菌。根据本发明的产乳酸细菌的剂量优选为102至1013、更优选105至1012、最优选108至5×1010个集落形成单位(cfu)的日剂量。
脂质源
本营养组合物优选包含脂质源。在本文中,脂质是包含至少85重量%、优选至少90重量%甘油三酯的任意混合物。因此,应认为脂质包括油和脂肪。脂肪在室温下是固体的,而油是液体或粘性的。
脂质源可包含植物来源的脂质(例如植物油,如橄榄、向日葵或菜籽油或椰子油)、动物来源的脂质(例如乳脂、猪油或鱼油)、或微生物脂质,例如通过特定微生物发酵获得的微生物脂质(例如由微生物得到的包含油的ARA或DHA)。
以干重为基准计,本发明组合物中的脂质源的量为0-50重量%,优选2-40重量%,更优选5-30重量%。或者,该组合物包含10-60en.%、优选35-50en.%的脂质源。
在优选实施方式中,脂质源包括至少一种长链多不饱和脂肪酸(LC-PUFA)。优选地,LC-PUFA是具有20或22个碳原子的长链的多不饱和脂肪酸,最优选二十碳五烯酸(EPA)、二十二碳六烯酸(DHA)和/或花生四烯酸(AA)。LC-PUFA优选作为甘油三酯混合物存在。如果甘油三酯包含至少1个LC-PUFA、优选2个或3个LC-PUFA、最优选3个LC-PUFA,则认为甘油三酯是LC-PUFA甘油三酯。
优选地,脂质源包含总甘油酯衍生的脂肪酸含量的至少0.1重量%的LC-PUFA,优选至少0.25重量%、更优选至少0.5重量%,甚至更优选至少0.75重量%。本发明组合物中LC-PUFA甘油三酯的含量优选不超过总脂质含量的15重量%,更优选不超过10重量%,甚至更优选不超过总脂质含量的5重量%。LC-PUFA有益地改进肠屏障功能,因此被认为能改进难消化纤维和产乳酸细菌组合物对使肠道微生物群正常化的功效。
蛋白质源
根据本发明的营养组合物优选包含蛋白质源。优选地,所述蛋白质对目标靶向群体是不会致敏的。在本文中,蛋白质是指包含至少90重量%、更优选至少95重量%的氨基酸的任意材料或材料混合物。蛋白质可包括天然蛋白质、变性蛋白质、水解蛋白质、至多10个氨基酸的肽、以及游离氨基酸。在优选的实施方式中,蛋白质包含至少70重量%的游离氨基酸,更优选至少80重量%、更优选至少90重量%、甚至更优选至少95重量%、最优选约100重量%的游离氨基酸。
在本文中,游离氨基酸是指已知存在于人体内并且形成其它活性蛋白质的标准氨基酸。游离氨基酸可以以其中性状态存在,或以生理学上可接受的盐的形式存在。合适的盐是本领域已知的,包括例如氨基酸的钠盐,钾盐和氯化物盐。
在根据本发明的组合物中,以总组合物的干重为基准计,蛋白质源的含量优选为2至40重量%的蛋白质,优选11至18重量%、甚至更优选12至16重量%的蛋白质。在替代性的优选实施方式中,蛋白质含量为5–50en.%,优选7.5–15en.%。
碳水化合物
根据本发明的组合物优选包含碳水化合物。在本文中,碳水化合物是可消化的碳水化合物,其包括营养领域中众所周知的单糖、双糖或三糖,以及可消化的寡糖和多糖(其中包括淀粉)。在优选实施方式中,碳水化合物包括葡萄糖、果糖及乳糖。
在优选实施方式中,以干重为基准计,所述组合物包含10-90重量%的碳水化合物,优选包含50-70重量%的碳水化合物。在替代性的优选实施方式中,所述组合物包含15–90en.%、优选40–55en.%的碳水化合物。
营养组合物和给予方式
本方法中使用的组合物优选肠内给予,更优选口服给予。本发明的组合物可以是包含难消化纤维和产乳酸细菌的组合物,该组合物可以在使用前进行分配,从而与任意市售婴儿配方混合,在该情况下用婴儿配方与本发明组合物的混合物进行喂养使得肠道微生物群正常化。
在优选实施方式中,本组合物作为营养基质给予或包含在营养基质中,所述营养基质优选含有脂质、蛋白质和碳水化合物组分。
对于年龄在0至36个月之间的婴儿或幼儿,优选将产乳酸细菌包埋在营养组合物中,所述营养组合物含有脂质源、碳水化合物和作为蛋白质源的游离氨基酸。
在优选的实施方式中,本发明的营养组合物满足喂养婴儿的要求、或者本发明的方法包括给予营养组合物,所述营养组合物满足喂养婴儿的要求,特别是述营养组合物含有10至60en.%的脂质源、5至50en.%的作为蛋白质源的游离氨基酸、和/或15至90en.%的碳水化合物。
更优选地,营养组合物包含7.5至15en.%的蛋白质源、40至55en.%的碳水化合物,和35至50en.%的脂质源(en%是能量百分比的缩写,表示每种成分对制剂的总卡路里值贡献的相对量)。
根据本发明的组合物可以是粉末或液体。优选地,所述组合物是粉末组合物,其在水中重构以形成具有粘性稠度或布丁状稠度的饮品或稠化产品。粉末的优点在于:具有活细菌的组合物的保质期将比产品为液体时更长。
优选实施方式是基于粉末状氨基酸的全营养组合物,例如具有至少108CFU短双歧杆菌和至少1g果寡糖的NeocateTM,用于使患有过敏症的患者肠道微生物群正常化。
该组合物优选用作婴儿或幼儿的主要营养。也就是说,婴儿或幼儿的总蛋白质摄入量的至少75重量%来源于该组合物。具有组合物的营养品优选每天、更优选每天1-10次、最优选每天3-8次。
Neocate含有约46en.%的脂质、43en.%的碳水化合物和11en.%的蛋白质当量[游离氨基酸L-精氨酸、L-天冬氨酸、L-亮氨酸、L-醋酸赖氨酸(L-lysineacetaat)、L-谷氨酰胺、L-脯氨酸、L-缬氨酸、甘氨酸、L-异亮氨酸、L-苏氨酸、L-苯丙氨酸、L-酪氨酸、L-丝氨酸、L-组氨酸、L-丙氨酸、L-胱氨酸、L-色氨酸(tryptofaan)、L-甲硫氨酸]以及最佳生长所必需的所有维生素和矿物质。在一个优选实施方式中,相对于每100g干重,所述组合物还包含约82mg二十二碳六烯酸(DHA)和82mg花生四烯酸(AA)。
此外,本发明公开了一种使基于氨基酸配方喂养的婴儿或幼儿的肠道微生物群正常化的方法,所述方法包括:每天用包含如上限定的难消化纤维和产乳酸细菌的组合物喂养所述婴儿或幼儿。在优选实施方式中,所述方法包括:基本仅用所述组合物作为蛋白质源来喂养婴儿或幼儿。
实施例
实施例1:在用母乳、基于牛乳的配方和基于氨基酸的配方喂养的婴儿的粪便中的平均双歧杆菌和梭菌属XIV簇计数
根据实施例2中描述的方法进行测量。
使用FISH探针Bif164测量双歧杆菌菌种(Bifido species),参见(http://probebase.csb.univie.ac.at/pb_report/probe/37)
ER/CC是指FISH-探针Erec482(参见:http://probebase.csb.univie.ac.at/pb_report/probe/963),并且其识别(大部分)“直肠真杆菌(Eubacterium rectale)-拟球梭菌(Clostridium coccoides)群体[梭菌属XIVa簇和XIVb簇也称为毛螺菌(Lachnospiraceae)科]”
由于婴儿的年龄可以影响肠道微生物群,因此用于该比较的婴儿的平均年龄保持在相同的范围内。数据来自多中心试验,从而也平衡了出生地和当地卫生水平的(潜在)影响。在这些婴儿的肠道微生物群中所发现的差异只能归因于它们消耗的营养。
结论:结果清楚地表明,与基于蛋白质的配方喂养的婴儿相比,用氨基酸喂养的婴儿具有较少的正常肠道微生物群。
母乳喂养 平均8.5个月大的婴儿
-双歧杆菌 55%
-ER/CC 6.5%
配方喂养 平均8个月大的婴儿
-双歧杆菌 30.1%
-ER/CC 38.1%
游离氨基酸喂养:平均8个月大的婴儿
-双歧杆菌 14.7%
-ER/CC簇为26.6%
游离氨基酸喂养:平均8.5个月大的婴儿
-双歧杆菌13%
-ER/CC 35.53%
实施例2:在安慰剂对照的双盲临床研究中显示出在氨基酸喂养的婴儿中微生物群正常化
使用双歧杆菌和梭菌属XIVa簇作为标记物来探索如下概念:用含有产乳酸细菌和难消化纤维的合生素(synbiotic)掺混物进行的氨基酸喂养可以改变患有CMA的婴儿的肠道微生物组成(肠道菌群或肠道微生物群),使其接近于在相当年龄的健康的母乳喂养的婴儿中所观察到的。对早期肠道菌群的研究表明,成熟至成人样概况可能延续超过5岁。通常健康的母乳喂养的婴儿中双歧杆菌丰富,并且与成人相比在童年早期显示出稳定和增加的水平。选择梭菌属XIVa簇作为该研究的标记物,因为其通常包含出现在婴儿肠道微生物群中的第一成体样簇之一。
方法:多中心双盲随机对照试验在<13个月大的非IgE介导的CMA对象中进行。选择健康的母乳喂养的婴儿(年龄与8周龄的患有CMA的婴儿相匹配)作为“健康参考”组。过敏对象被随机分配,以接受试验或对照产品8周。试验产品是低过敏性的基于氨基酸的全营养配方,其含有果寡糖的益生元掺混物和益生菌菌株短双歧杆菌M-16V。对照产品是基于相同氨基酸的配方,但不含益生元掺混物,也不含益生菌菌株。产品包装完全相同,以确保不能区分。
基线评估(第0周)包括通过24小时召回提出投诉的临床医生报告的病史。父母/监护人(如果可能的话,在医疗保健专业人员的监督下)在第0周收集用于分析的粪便样品,然后在第8周在家中收集用于分析的粪便样品。将收集到10mL粪便容器(Greiner Bio-One,Kremsmünster,奥地利)中的样品在诊所中冷冻于-80℃,或者在家用冷冻于-20℃的冷冻箱中,然后转移到临床存储设施。
主要目的是评估试验产品对双歧杆菌和梭菌属XIVa簇的粪便水平的影响,其通过使用16S rRNA靶向寡核苷酸探针的荧光原位杂交(FISH)分析来确定,如[Clin ExpAllergy 2010;40(5):795-804]中所述。
结果:35名对象被随机分配至试验产品中,并且36名对象被随机分配至对照产品;健康参考组包括51名婴儿。包括所有随机对象,以意图进行处理分析。在第8周,试验和对照产品之间的双歧杆菌(较高)(图1)和梭菌属XIVa簇(较低)(图2)水平显著不同(P<0.001)。试验组中的微生物群水平接近健康参考组中的水平。在试验组和对照组之间在所报告的不良事件上没有差别。
结论:膳食纤维和短双歧杆菌的组合能够使用基于氨基酸的配方喂养的婴儿中的肠道微生物失调正常化。产乳酸细菌的比例增加,梭菌属细菌的比例下降。
实施例3.用于本发明应用的组合物
表1:组合物
单位 | 每100克干重 | 每100ml<sup>1</sup> |
能量[kcal] | 483 | 67 |
蛋白质(参见表2)[g] | 13 | 1.8 |
总能量的%[en.%] | 10.8 | 10.8 |
可消化碳水化合物[g] | 52.5 | 7.3 |
糖[g] | 4.7 | 0.65 |
总能量的%[en.%] | 43.5 | 43.5 |
脂质[g] | 24.5 | 3.4 |
总能量的%[en.%] | 45.7 | 45.7 |
不饱和脂肪[g] | 8.9 | 1.2 |
单不饱和脂肪[g] | 9.6 | 1.3 |
多不饱和脂肪[g] | 4.8 | 0.67 |
DHA[mg] | 110 | 15 |
ARA[mg] | 110 | 15 |
纤维<sup>2</sup>:scFOS+lcFOS[g] | 4.9 | 0.68 |
乳酸细菌<sup>3</sup> | 短双歧杆菌M-16V | 短双歧杆菌M-16V |
1)14.7g粉末溶解在100ml水中
2scFOS:lcFOS比率=9:1
3短双歧杆菌M-16V:1.9x109CFU每克纤维
表2:蛋白质源的组成
蛋白质源是具有以下组成[g/100g组合物]的游离氨基酸的混合物:
Claims (15)
1.一种包含难消化纤维和产乳酸细菌的营养组合物,用于使得用基于氨基酸的配方喂养的婴儿或幼儿中的肠道微生物群正常化。
2.如权利要求1所述的营养组合物,其中,所述产乳酸细菌是双歧杆菌。
3.如权利要求2所述的营养组合物,其中,双歧杆菌选自下组:短双歧杆菌、长双歧杆菌、婴儿双歧杆菌和乳双歧杆菌。
4.如权利要求2或3所述的营养组合物,其中,所述双歧杆菌是短双歧杆菌。
5.如前述权利要求中任一项所述的营养组合物,其中,产乳酸细菌的浓度为每克难消化纤维2.0x108至2.0x1011CFU产乳酸细菌。
6.如前述权利要求中任一项所述的营养组合物,其中,以所述组合物的干重为基准计,难消化纤维的浓度为0.25–7.5重量%。
7.如前述权利要求中任一项所述的营养组合物,其中,所述难消化纤维选自下组:半乳寡糖、果寡糖、果多糖、岩藻寡糖、聚右旋糖、阿拉伯树胶或其衍生物、以及果胶或其衍生物。
8.如前述权利要求中任一项所述的营养组合物,其中,所述难消化纤维选自下组:果寡糖、非牛乳衍生岩藻寡糖和聚右旋糖。
9.如前述权利要求中任一项所述的营养组合物,所述组合物还包含蛋白质源。
10.如权利要求9所述的营养组合物,其中,蛋白质源包含至少70重量%的游离氨基酸。
11.如前述权利要求中任一项所述的营养组合物,其中,所述营养组合物还包含脂质源。
12.如权利要求11所述的营养组合物,其中,脂质源包括至少一种长链不饱和脂肪酸(lcPUFA),优选二十碳五烯酸(EPA)、二十二碳六烯酸(DHA)和/或花生四烯酸(AA)。
13.如前述权利要求中任一项所述的营养组合物,其中,婴儿或幼儿具有食物过敏症或氨基酸代谢疾病。
14.如权利要求13所述的营养组合物,其中,所述食物过敏症是牛乳过敏症(CMA)。
15.如权利要求13所述的营养组合物,其中,所述氨基酸代谢疾病是:苯丙酮尿症、枫糖尿症、戊二酸血症和甲基丙二酸血症。
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