CN102919663B - 预防剖腹产分娩的婴儿疾病的方法 - Google Patents

预防剖腹产分娩的婴儿疾病的方法 Download PDF

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CN102919663B
CN102919663B CN201210414761.2A CN201210414761A CN102919663B CN 102919663 B CN102919663 B CN 102919663B CN 201210414761 A CN201210414761 A CN 201210414761A CN 102919663 B CN102919663 B CN 102919663B
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bifidobacterium
composition
oligosaccharide
baby
digest
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CN102919663A (zh
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琼希姆·施密特
伯恩德·斯塔尔
詹·诺尔
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Nutricia NV
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Nutricia NV
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Abstract

本发明提供了一种包含非消化低聚糖的组合物在制备用于肠道给予剖腹产分娩婴儿的组合物中的应用。

Description

预防剖腹产分娩的婴儿疾病的方法
技术领域
本发明涉及治疗和/预防剖腹产分娩婴儿疾病的方法
背景技术
人乳包含了非消化低聚糖，这些低聚糖能特异地促进产乳酸细菌的生长，比如属于双歧杆菌属和乳酸菌属的一些细菌，并且能预防其他致病菌的生长和/或其对肠壁的粘附。因此，当婴儿得到了人乳的哺乳，这个婴儿的肠道菌群发育成含有丰富产乳酸细菌的健康菌群。健康肠道菌群的存在能够促进肠屏障的成熟和/或完整，促进粘液的形成和抑制病原菌的生长，并且增强免疫系统。
WO0008984涉及一种用于促进大肠天然菌群中的健康的微生物的健康和增加的非消化的碳水化合物混合物。
在出生前婴儿的肠道通常是无菌的。在阴道分娩的过程中，婴儿的肠道接种了母亲阴道和/或排泄物的细菌，导致婴儿的胃肠道被来源于其周围环境的细菌的侵袭。
Natren公司生产了益生菌产品Life这种产品是专为婴儿设计的并且适合剖腹产分娩的婴儿。Life是用婴儿双歧杆菌制成的。因为这种Life产品仅仅包含唯一的一种双歧杆菌菌种，这样对于婴儿的益处就会非常有限。
发明内容
本发明发现剖腹产分娩的婴儿体内有不同于阴道分娩的婴儿的肠道菌类的肠道菌类。尤其是剖腹产分娩的婴儿双歧杆菌定殖的速度延迟，并且肠道双歧杆菌菌种多样化比阴道分娩的婴儿也要少，尤其是缺少短双歧杆菌，长双歧杆菌，婴儿双歧杆菌，分叉双歧杆菌。
进一步发现，剖腹产分娩的婴儿相对于阴道分娩的婴儿的肠道菌群中双歧杆菌的含量偏低。而且在出生后6周的剖腹产分娩的婴儿的肠道菌群中发现含有高含量的(不希望的)大肠杆菌。
本发明的发明人发现这些婴儿肠道菌群的缺陷可以通过将非消化低聚糖给予剖腹产婴儿来克服，优选包含在给予剖腹产婴儿的营养物中。特别地，给予非消化低聚糖可以增加剖腹产婴儿体内双岐杆菌的含量，并且减少大肠杆菌的含量。克服了这些缺点就会促进健康并且预防和/或治疗多种疾病。
健康和完全形成的胃肠道菌群有着重要的生理功效。一个重要的方面就是它能降低胃肠道感染的发生。因为剖腹产分娩的婴儿缺乏健康的菌群，对于这些婴儿来说，预防感染显得尤为重要。这些婴儿通常在医院的环境生产，由于医源性细菌的存在使剖腹产有病原感染的风险。而且，相对于婴儿的肠道被母亲的细菌接种的情况，健康肠道菌群的弱势发育导致了病原细菌的迅速定殖。
本发明尤其是旨在减少剖腹产婴儿的(胃肠道)感染的次数和严重性，通过(i)促进有益菌的生长，尤其是产乳酸细菌的生长，(ii)减少病原菌的生长；和/或(iii)减少病原菌对肠道上皮细胞和/或肠道粘液的吸附。
本发明的发明人发现能够通过非消化低聚糖，尤其是低聚半乳糖预防和治疗(胃肠道)感染。本发明的非消化低聚糖适合于肠道给予(特别是口服)，使得它们易于包含在婴儿配方奶粉中。由于肠道病原菌浓度的减少，特别是金黄色葡萄球菌，表皮葡萄球菌，溶血链球菌，链球菌，艰难梭菌，枯草芽孢杆菌，铜绿假单胞菌，肠杆菌，克雷伯菌属，不动杆菌，变形杆菌，气单胞菌和大肠杆菌浓度的减少，本发明的非消化低聚糖减少了感染的发生，也降低了感染的严重性。
通过提供至少含有两种具有不同结构和不同聚合度(DP)的非消化低聚糖的混合物，甚至可以进一步减少剖腹产婴儿的感染的发生和严重度，甚至可以通过提供除非消化中性低聚糖之外的酸性低聚糖，尤其是糖醛酸低聚糖来进一步减少。具有不同结构和/或不同聚合度的非消化低聚糖的混合物可以协同促进健康胃肠道菌群的发育。低聚半乳糖和/或低聚果糖可以特别地适合促进长双歧杆菌，短双歧杆菌和/或婴儿双歧杆菌的生长(实施例2)。糖醛酸低聚糖可以阻止病原菌向肠道壁的粘附，因此可以进而预防和/或治疗病原菌引起的感染。
除了减少了感染的发生以外，通过本发明的方法也可以预防和/或治疗剖腹产婴儿的其他疾病。尤其是诸如过敏和湿疹的疾病可以通过促进健康肠道菌群而预防和/或治疗。
另一个方面，本发明能够通过将上述的活性组分掺入到一种营养组合物中而恰当的进行实践。这种组合物可以给予婴儿并且不会引起剖腹产分娩的婴儿过重的负担。
发明的详细描述
本发明提供了一种包含非消化低聚糖的组合物的应用，该组合物用于制造用于(i)治疗和/或预防剖腹产分娩的婴儿疾病和/或(ii)促进剖腹产分娩的婴儿的健康的组合物。
另一方面，本发明提供了一种用于(i)治疗和/或预防剖腹产分娩的婴儿疾病和或(ii)促进剖腹产分娩的婴儿的健康的方法，上述的方法包括将非消化低聚糖给予剖腹产分娩的婴儿，特别是用于预防和/或治疗剖腹产分娩的婴儿的感染和/或用于预防和/或治疗剖腹产分娩的婴儿的过敏的方法。
另一方面，本发明提供了一种促进剖腹产分娩的婴儿健康肠道菌群的发育和/或减少肠道病原菌的发生的方法，这种方法包括以下步骤：a)将I)营养学或药学可接受的液体和II)干燥的组合物混合，其中干燥的组合物II包含非消化的低聚糖，并且b)将步骤a)中得到的组合物给予婴儿。
另一方面，本发明提供了一种促进剖腹产分娩的婴儿健康肠道菌群的发育和/或减少肠道病原菌的发生的方法，这种方法包括给予婴儿一种包含非消化低聚糖的组合物。
另一方面，本发明提供了一种为剖腹产分娩的婴儿提供营养的方法，上述方法包含以下步骤：a)将I)包含非消化低聚糖的组合物和给予剖腹产分娩的婴儿的营养物混合，并且b)将步骤a)中得到的混合物给予剖腹产分娩的婴儿。本发明也涉及组合物，所述组合物包含占组合物干重至少5wt.％的非消化低聚糖和占组合物干重至少1wt.％的糖醛酸低聚糖。
剖腹生产术
本发明涉及向剖腹产分娩的婴儿肠道给予一种包含非消化低聚糖的组合物。剖腹产(c-section)是一种外科生产程序，其中婴儿是通过切开母亲的腹壁和子宫壁而分娩出来的。通常剖腹产是当相对于阴道分娩对母亲或婴儿更安全时被施行。作为一种选择，产妇可以选定剖腹产而不进行阴道分娩。
非消化低聚糖
本发明的组合物包含一种非消化低聚糖，所述非消化低聚糖尤其能够促进肠道产乳酸细菌，特别是双歧杆菌和乳酸杆菌的生长。
本发明中所使用的术语“低聚糖”是指具有聚合度(DP)为2-250的糖类，优选的聚合度为2-100，更优选的是聚合度为2-60，甚至更优选的聚合度为2-10。如果聚合度为2-100的低聚糖包含在上述的组合物中，这种的组合物包含聚合度为2-5，聚合度为50-70和聚合度为7-60的混合物。在本发明中所使用的术语“非消化低聚糖”是指在人上消化道(小肠和胃)中的酸或消化酶的作用下在肠中不能被消化或者仅仅被部分消化，而是被人肠道菌群进行发酵的低聚糖。例如蔗糖，乳糖，麦芽糖和糊精被认为是可消化的。优选所述非消化低聚糖是非消化中性低聚糖。在本发明中使用的术语“中性低聚糖”是指其中超过75％的糖类单位是选自葡萄糖，果糖，半乳糖，甘露糖，核糖，鼠李糖，树胶醛糖和木糖的低聚糖，，优选是超过85％，更优选是超过95％，甚至更优选是超过99％。首选的非消化中性低聚糖是低聚反式半乳糖和低聚果糖。
优选上述非消化低聚糖是益生元低聚糖。术语“益生元低聚糖”是指通过有选择地促进结肠中的一种或少数几种益生菌种类的生长和/或活动，从而对宿主产生有益的作用的非消化低聚糖。
优选上述非消化低聚糖是可溶的。当涉及多糖，纤维或低聚糖时，在这里使用的术语“可溶”意思是指至少根据L.Proskyet al.,J.Assoc.Off.Anal.Chem.71,1017-1023(1988)描述的方法，该物质是可溶的。
优选上述组合物包括至少一种非消化低聚糖，所述非消化低聚糖选自低聚半乳糖，非消化糊精，低聚木糖，低聚阿拉伯糖，低聚葡萄糖(包括龙胆低聚糖和环式糊精)，甲壳低聚糖，低聚岩藻糖，低聚甘露糖，低聚异麦芽糖，低聚果糖(包括菊糖)，葡甘露低聚糖，半乳甘露低聚糖，阿拉伯半乳糖低聚糖，更优选至少包含低聚半乳糖和/或低聚果糖，最优选至少包含低聚半乳糖。
这里提到的术语“低聚果糖”是指一种非消化多聚糖碳水化合物，它含有一个至少有2个β-连接的果糖单位的链，聚合度为2-250，较好是聚合度为7-100，更好是聚合度在20-60。优选使用菊糖。菊糖的商标是“Raftilin”，(Orafti)。上述低聚果糖的平均聚合度优选至少为7，更优选至少为10，优选低于100。使用的低聚果糖优选具有(大多数)β(2→1)键连接的果糖单元。对于低聚果糖的其他术语包括例如菊糖，果糖多聚糖，多聚果糖，果聚糖和果寡糖。上述的组合物优选包含聚合度为2-100的低聚果糖。
非消化糊精是指能够抵抗消化的(麦芽)糊精或多聚糊精，它们具有10-50的聚合度，较好是10-20的聚合度。非消化糊精优选含有α(1→4)，α(1→6)糖苷键且具有1→2和1→3连接。非消化糊精的商标是来自Matsutami产业的“Fibersol”或Danisco公司的
本发明的发明者发现低聚半乳糖能够有效地应用于本发明的组合物中，因为这些低聚糖能特别促进双歧杆菌的生长。因此，本发明的组合物中优选包含低聚半乳糖。在这里提到的术语“低聚半乳糖”是指非消化的低聚糖，其中至少30％的糖单元是半乳糖单元，较好至少50％，更好是至少60％。本发明的组合物优选包含聚合度为2-100的低聚半乳糖，更好的是包含聚合度是2-10。优选低聚半乳糖中的这些糖单元是以β连接的方式连接的，如同人乳中低聚糖的情况。
本发明组合物中优选包含一种选自反式低聚半乳糖，乳糖-N-四糖(LNT)和乳糖-N-新四糖(neo-LNT)的低聚半乳糖。特别优选的例子是本发明的方法包含反式低聚半乳糖([半乳糖]n-葡萄糖；其中n是在1至60之间的整数，也就是2，3，4，5，6，....59，60；优选是2，3，4，5，6，7，8，9和/或10)的给予。例如反式低聚半乳糖(TOS)是以商标名VivinalTM(Borculo Domo Ingredients公司，荷兰)在销售。
本发明的组合物优选每100g干重包含0.5-75g非消化低聚糖，较好是0.5-50g。本发明的组合物中较好是每100g干重包含0.1-75g低聚半乳糖，优选是包含0.1-50g。
本发明的方法优选是包含0.05-25g非消化低聚糖/餐的给予，优选是在0.1-5g。本发明的方法优选包含0.05-25g低聚半乳糖/餐的给予，优选在0.1-5g低聚半乳糖。
本发明的发明者也发现长链非消化(中性)低聚糖和短链非消化(中性)低聚糖的混合物能够协同促进健康肠道菌群的生长，尤其是双歧杆菌并且能减少剖腹产分娩的婴儿体内的大肠杆菌的发生。
本发明的组合物因此优选包含至少两种具有不同平均聚合度(DP)的非消化的(中性)低聚糖。优选地重量比为：
a.(聚合度为2-5的非消化(中性)低聚糖)：(聚合度为6，7，8和/或9的非消化(中性)低聚糖)＞1；和/或
b.(聚合度为10-60的非消化的(中性)低聚糖)：(聚合度为6，7，8和/或9的非消化(中性)低聚糖)＞1；
较好的是两种重量比都大于2，甚至更好为大于5。
为了进一步的改进，上述非消化低聚糖优选具有相对高含量的短链低聚糖，因为这些低聚糖可以强烈的促进双歧杆菌的生长。因此，优选至少10wt.％的非消化低聚糖的聚合度为2-5(也就是2，3，4，和/或5)并且至少5wt.％聚合度为10-60。至少50wt.％的非消化中性低聚糖具有2-9的聚合度(也就是2，3，4，5，6，7，8，和/或9)是比较好的，至少75wt.％则更好。
为了促进生物多样性和促进肠道微生物的多样性的生长，本发明的组合物优选包含两种具有不同结构的非消化低聚糖。本发明的组合物较好包含至少两种不同的非消化(中性)低聚糖，其中非消化低聚糖具有90％以下同源性的糖单元，较好是50％以下，甚至更好是25％以下，甚至更优选地是5％以下。在本发明中提到的术语“同源性”是同样的糖单元在不同的非消化低聚糖中的百分比的累积。例如，低聚糖1(OL1)具有fruc-fruc-glu-gal的结构，因此其包含50％的fruc(果糖)，25％gal(半乳糖)和25％glu(葡萄糖)。低聚糖2(OL2)具有fruc-fruc-glu的结构，因此其包含66％fruc，33％glu。不同的低聚糖因此具有75％同源性(50％fruc+25％glu)。
本发明的组合物优选包含低聚半乳糖和低聚果糖，较好的是包含具有聚合度为2-7的反式低聚半乳糖和聚合度为10-100的低聚果糖。
糖醛酸低聚糖
本发明组合物中优选包含糖醛酸低聚糖，更优选包含非消化中性低聚糖和糖醛酸低聚糖的组合。糖醛酸低聚糖(进一步地)减少病原菌对肠道上皮细胞的粘附并且抑制了肠道病原菌的定植。
本发明中使用的术语糖醛酸低聚糖涉及一种低聚糖，该低聚糖中至少25％的单糖单元是糖醛酸，优选至少在低聚糖中50％单糖单元是一种选自古罗糖醛酸，甘露糖醛酸，艾杜糖醛酸，riburonic acid，半乳糖醛酸，葡萄糖醛酸的糖醛酸。首选的糖醛酸低聚糖应包含至少占糖醛酸低聚糖中全部糖醛酸单元50％的半乳糖醛酸。本发明中使用的糖醛酸低聚糖较好的是来源于果胶，果胶酸盐，藻酸盐，软骨素，透明质酸，肝磷脂，乙酰型肝素，细菌糖类，唾液酸多糖，岩藻依聚糖，岩藻低聚糖和/或卡拉胶，更好是来源于果胶和/或藻酸盐，甚至更好的来源是果胶，最好是来源于多聚半乳糖醛酸。上述的糖醛酸低聚糖优选是果胶降解产物和/或藻酸盐降解产物。果胶降解产物优选是一种果胶水解产物(经过水解制成)和/或是果胶溶解产物(经过β-降解)。果胶降解产物较好的是由水果胶质和/或蔬菜胶质制备而成的，更好的是苹果胶质，柑橘类胶质和/或甜菜胶质，更优选是由苹果，柑橘类和/或甜菜胶质制备。这种果胶降解产物较好的是经裂解酶和/或温度、压力的变化得到的，更好的是经果胶溶解产物制得，即经β-降解的果胶溶解产物。这种果胶降解产物较好的是胶质溶解产物。
上述的组合物较好的是包含具有2-250个聚合度(DP)的糖醛酸低聚糖，更好的是具有2-100个聚合度，甚至更好是有2-50个聚合度，最好地是具有2-20个聚合度。上述组合物较好的是包含占该组合物中糖醛酸的总重量的25-100wt.％，更好地是50-100wt.％的具有2-250个聚合度，更好的是2-100个聚合度，甚至更好是2-50个聚合度，最好地是2-20个聚合度糖醛酸低聚糖。
上述的糖醛酸低聚糖优选是通过果胶裂解酶，内切多聚半乳糖醛酸酶和/或果胶酶对果胶进行消化得到的。
一个首选的例子是糖醛酸低聚糖中至少在一个末端己糖醛酸单元有一个双键，这个双键优选位于末端的己糖醛酸单元C4和C5之间。这个双键能有效的抵抗致病细菌粘附到肠道上皮细胞。优选有一个末端的己糖醛酸单元含有一个双键。例如这个末端的己糖醛酸单元双键能够通过用裂解酶酶水解果胶而得到。
进一步的例子使用了具有不同的聚合度和/或包含不饱和的及饱和的末端的己糖醛酸单元的糖醛酸低聚糖混合物。较好的是至少5％的糖醛酸低聚糖中的末端的己糖醛酸单元是一个不饱和的己糖醛酸单元，更好是至少10％，甚至更好是25％。由于每一个单独的糖醛酸低聚糖优选仅含有一个不饱和的末端己糖醛酸单元，优选不超过50％的末端己糖醛酸单元是不饱和的己糖醛酸单元(也就是含有一个双键)。糖醛酸低聚糖混合物优选包含占末端己糖醛酸单元总量2％-50％的不饱和末端己糖醛酸单元，优选在10％-40％之间。
糖醛酸低聚糖可以被衍生化。糖醛酸低聚糖可以被甲氧基化和/或酰胺化。一个首选的例子是糖醛酸低聚糖甲氧基化度超过20％，更好是超过30％，甚至更好是超过70％。在这里，“甲氧基化度”(也可以为DE或“酯化度”)是要平均在糖醛酸低聚糖中的游离的羧酸基被酯化(例如被甲氧基化)的程度。在另外一个首选的例子中，糖醛酸低聚糖的甲基化度超过20％，较好的甲基化度是30％甚至超过70％。
上述组合物优选是每100g上述的组合物干重含有0.01-10g聚合度为2-250的糖醛酸低聚糖，更好是含有0.05-6g，甚至更好是含有0.2-2g。上述的组合物优选是每100g上述组合物干重含有0.01-10g聚合度为2-250(更好是聚合度为2-100)的半乳糖醛酸低聚糖，更好是在0.05-6g，甚至更好是0.2-2g。
糖醛酸低聚糖在人体上消化道内优选是非消化的并且是水溶性的(根据L.L.Prosky et al,J.Assoc.Anal.Chem 71:1017-1023,1988所揭露的方法)。糖醛酸低聚糖优选是可被肠道菌群发酵的。本发明中的糖醛酸低聚糖有效地减少了致病微生物对肠道上皮细胞的粘附，因此减少了剖腹产分娩婴儿结肠中医源性致病细菌的定殖。此外，本发明中的糖醛酸低聚糖优选促进健康肠道菌群的形成而且被发酵，导致肠道有机酸的产生和降低肠道pH值，这样能够抑制(医源性)致病细菌的生长。
产乳酸细菌
本发明组合物最好包含活的或是死的产乳酸细菌。产乳酸细菌优选提供为活的微生物的单一或混合的培养物。每克本发明组合物干重应包含102-1013个产乳酸细菌的集落形成单元(cfu)，较好是102-1012，更好是105-1010，最好是104-5x109cfu.。
本发明组合物优选包含乳酸菌属或者双歧杆菌属的细菌。本发明组合物至少包含一种选自长双歧杆菌，短双歧杆菌，婴儿双歧杆菌，链状双歧杆菌，假小链双歧杆菌，青春双歧杆菌，动物双歧杆菌，高卢双歧杆菌，乳双歧杆菌和分叉双歧杆菌的双歧杆菌，较好是短双歧杆菌，婴儿双歧杆菌，分叉双歧杆菌，链状双歧杆菌，长双歧杆菌，更优选是长双歧杆菌和短双歧杆菌，最优选是短双歧杆菌。优选上述组合物至少包含两种不同的双歧杆菌菌种，亚种或者菌株。本组合物优选至少包含一种，更好的是至少包含两种，甚至更好的是包含三种，甚至最好的是包含四种不同的双歧杆菌菌种。本组合物优选至少包含一种，更好的是至少包含两种，甚至更好的是包含三种，甚至最好的是包含四种不同的双歧杆菌菌株。本组合物优选至少包含长双歧杆菌和短双歧杆菌。通常的上面提到的组合的目的在于增加剖腹产分娩的婴儿肠道中的微生物的种类和/或数量。这有利的影响婴儿并提供大量的健康益处。
本发明的组合物优选包含一种乳酸菌，乳酸菌选自于干酪乳杆菌，罗伊氏乳酸杆菌，副干酪乳杆菌，鼠李糖乳杆菌，嗜酸乳杆菌，约氏乳杆菌，乳酸乳球菌，唾液乳酸杆菌，卷曲乳杆菌，格氏乳酸杆菌，玉米乳杆菌，发酵乳杆菌和植物乳杆菌；较好的是干酪乳杆菌，副干酪乳杆菌，鼠李糖乳杆菌，约氏乳杆菌，嗜酸乳杆菌，发酵乳杆菌；最好是副干酪乳杆菌。甚至更好地，本发明的组合物包含短双歧杆菌和/或副干酪乳杆菌，因为相比母乳喂养的婴儿在配方喂养的婴儿的肠道中这些细菌的生长要受损。进一步增加的生物多样性对剖腹产分娩的婴儿的健康会带来促进的作用。
长链多不饱和脂肪酸
本发明的组合物优选包含长链多不饱和脂肪酸(LC-PUFA)。LC-PUFA是具有22-24个碳原子，优选是20-22个碳原子的，且有两个或更多不饱和键的脂肪酸或脂肪酰基链。本发明的组合物更优选包含二十碳五烯酸(EPA，n-3)，二十二碳六烯酸(DHA，n-3)和/或花生四烯酸(ARA，n-6)，因为这些LC-PUFA能够高效地减少肠道紧密连接的渗透性。降低了的紧密联结的渗透性减少了感染的发生并且/或者减少了过敏原的通过。因此在本发明的组合物中的EPA，DHA和/或ARA的并入能够增强肠屏障的完整性，这对于剖腹产分娩的婴儿来说是非常重要的，因为这些婴儿只有不太完善的肠道菌群，因此他们只有成熟较缓慢的肠屏障。这些LC-PUFA的并入会进一步地(协同)促进降低感染和过敏的发生和严重度。
由于低浓度的ARA，DHA和/或EPA已经能够有效地减低紧密联结的渗透性，在本发明的组合物当中的具有20-22个碳原子的LC-PUFA的含量较好不要超过总脂肪含量的15wt.％，更好是不要超过总脂肪含量的10wt.％，甚至更优选地不要超过总脂肪含量的5wt.％。本发明组合物优选包含至少占总脂肪含量0.1wt.％，较好是至少0.25wt.％，更好是至少0.6wt.％，甚至更好是至少0.75wt.％的具有20-22个碳原子的LC-PUFA。由于相同的原因，EPA的含量优选不要超过总脂肪含量的5wt.％，更好的是不要超过1wt.％，但是优选至少要占总脂肪含量的0.03wt.％，更好的是至少0.05wt.％。DHA的含量较好不要超过总脂肪含量的5wt.％，更好不要超过1wt.％，但是至少是总脂肪含量的0.1wt.％。既然ARA被发现对降低紧密联结的渗透性特别有效，本发明组合物包含相对高的含量，较好至少为总脂肪量的0.1wt.％，甚至更好是至少0.25wt.％，最好是至少0.35wt.％。ARA的含量较好不要超过5wt.％，更好是不要超过总脂肪量的1wt.％。当上述的肠道组合物成分包含ARA时，加入EPA和DHA有利于平衡ARA的作用，例如：减少ARA代谢产物潜在的促炎症反应的作用。过量的ARA的代谢产物能够引起炎症反应。因此，上述组合物优选包含ARA，EPA和DHA，上述组合物中ARA/DHA的重量比是0.25以上，较好是0.5以上，甚至更好是1以上。这个比率较好是低于25，更好是低于15。ARA/EPA的重量比率较好是在1-100之间，更好是5-20之间。
上述组合物较好是包含占总脂肪量5-75wt％的多不饱和脂肪酸，较好是10-50％。
LC-PUFA的含量，尤其是具有20-22个碳原子的LC-PUFA，较好是不要超过总脂肪含量的3％，这样才能尽可能地模拟接近人乳。可以以丰富的脂肪酸，甘油三酸酯，甘油二酯，甘油一酸酯，磷脂，或者是以上其中一种或更多的混合物提供LC-PUFA。本组合物优选包含磷脂形式的ARA和DHA中的至少任何一种。
核苷酸
本发明的组合物优选包含核苷酸和/或核苷，尤其是包含核苷酸。它优选包含5′-胞苷酸、5′-尿苷酸、5′-腺苷酸、5′-鸟苷酸和/或5′-次黄苷酸，尤其是包含5′-胞苷酸、5′-尿苷酸、5′-腺苷酸、5′-鸟苷酸和5′-次黄苷酸。
本发明的组合物每100g组合物干重较好包含5-100mg，更好是包含5-50mg，最好是包含10-50mg的核苷酸和/或核苷。核苷酸和/或核苷能够有利地增强婴儿的肠的生长和成熟，对于剖腹产分娩的婴儿来说是至关重要的。核苷酸和/或核苷能进一步的促进免疫系统，因此能够增强对诸如大肠杆菌的肠道内病原菌高负荷的抵抗。核苷酸和/或核苷被认为与本发明组合物其他组分协同作用。
配方奶粉
本发明组合物较好地是肠道给予，更优选地口服。
本发明组合物优选是营养配方，尤其是婴儿的配方。本发明组合物能够被有效地作为婴儿的完全营养物。本发明组合物应包含一种脂质成分，蛋白成分和碳水化合物成分并且能够较好的以液体的形式给予。本发明包括干燥性食品(例如粉末)，并随附关于用适量的液体(例如：水)来混合上述的干燥性食品的说明。
本发明方便的提供了一种组合物，其中脂质成分提供总热量的5-50％，蛋白成分提供总热量的5-50％，碳水化合物成分提供总热量的15-90％。优选在上述组合物中脂质成分提供总热量的35-50％，蛋白质成分提供总热量的7.5-12.5％，碳水化合物成分提供总热量的40-55％。为了计算蛋白质成份所提供热量占总热量的百分比，由蛋白质、肽类和氨基酸提供的总能量需要被考虑在内。
本发明组合物优选包含选自动物油脂(不包括人体油脂)和蔬菜油脂的至少一种油脂。较好地，本发明组合物包含蔬菜油脂，及鱼油、动物油、藻类油、真菌油和细菌油中的至少一种。本发明的组合物包含除人乳以外的非消化低聚糖。
在上述的营养备料中的蛋白质成份较好是选自非人类的动物蛋白(优选是奶蛋白)，蔬菜蛋白(优选是大豆蛋白和/或大米蛋白)，游离的氨基酸和它们的混合物。牛奶来源的氮源。本发明的组合物较好含有酪蛋白，乳清，酪蛋白酶解液和/或乳清蛋白酶解液。优选所述蛋白含有完整蛋白，更优选地含有完整的牛乳清蛋白和/或完整的牛酪蛋白。因为本发明组合物非常适合被用于减少婴儿的过敏反应，所述蛋白质优选选自水解的牛乳蛋白。优选本发明的组合物含有水解酪蛋白和/或水解乳清蛋白，蔬菜蛋白和/或氨基酸。这些蛋白的使用可以进一步减少婴儿的过敏反应。这些水解蛋白的使用可以有利地促进食物中的蛋白质成份通过剖腹产分娩的婴儿的未成熟的肠道的吸收。
本发明的组合物优选包含选自蔗糖，乳糖，葡萄糖，果糖，淀粉糖浆干粉，淀粉和麦芽，以及他们的混合物的可消化的碳水化合物，更好是乳糖。
不规则的大便(例如：过硬的大便，不足的大便体积，腹泻)是剖腹产分娩的婴儿中重要的问题。这些可能是由于粪便中大量的大肠杆菌的引起的。研究发现大便的问题可以通过在液体的食物中给予渗透压为50-500mOsm/kg，更好是在100-400mOsm/kg之间的上述的非消化低聚糖来减少。减少了无规则的大便就会增强健康肠道菌群的定殖和发育。
根据上面的叙述，虽然仍需给主体提供充足的热量，但是液体的食物不能含有过量的热量密度也是很重要的。因此，液体食物较好应含有在0.1-2.5kcal/ml的热量密度，甚至更好是含有0.5-1.5kcal/ml，最好是含有0.6-0.8kcal/ml。
浓缩的非消化低聚糖
根据进一步首选的实例，本发明提供了对于向剖腹产分娩的婴儿提供营养的一种方法，其中将含有低聚糖，优选是含有高含量低聚糖的浓缩的组合物混合到给予剖腹产分娩婴儿的营养物中。提供浓缩的形式使得可以将本发明的非消化低聚糖添加到人造的婴儿配方奶粉和母乳中。
因此本发明提供了对于向剖腹产分娩的婴儿提供营养的一种方法，上述方法包括以下步骤：
a)将含有非消化低聚糖的组合物混合到给予剖腹产分娩婴儿的营养物中；并且
b)将步骤a)中得到的混合物给予剖腹产分娩的婴儿。
在本方法中步骤a)中提到的营养物较好应是婴儿配方乳粉或者是人乳，包含步骤a)中使用的非消化低聚糖的组合物是浓缩的非消化低聚糖组合物或者换句话说是含有高含量的非消化低聚糖的组合物。
在上述方法中步骤a)中使用的包含非消化低聚糖的组合物，较好是应包含占组合物干重的至少5wt％，更好是至少10wt％，更优选是至少25wt％的非消化低聚糖。其中所述非消化低聚糖优选选自低聚半乳糖，非消化糊精，低聚木糖，低聚阿拉伯糖，低聚葡萄糖(包括龙胆低聚糖和环式糊精)，甲壳低聚糖，低聚岩藻糖，低聚甘露糖，低聚异麦芽糖和低聚果糖(包括菊糖)。可以通过与一种或多种上述揭露的成分组合，优选是与选自糖醛酸低聚糖，LC-PUFA，核苷酸和益生菌的一种或多种或者全部组合来改善该组合物。
本发明也同样提供了一种组合物，这种组合物可以被恰当的在本发明的方法中与营养物混合，也就是，含有高浓度的非消化的中性低聚糖的组合物。这种组合物包含占其干重的至少5wt％(更好是至少10wt％)的非消化低聚糖，和优选如上所述占所述组合物干重至少1wt.％(优选至少10wt.％)的糖醛酸低聚糖，其中所述非消化低聚糖优选选自低聚半乳糖，非消化的糊精，低聚木糖，低聚阿拉伯糖，低聚葡萄糖(包括龙胆低聚糖和环式糊精)，甲壳低聚糖，低聚岩藻糖，低聚甘露糖，低聚异麦芽糖和低聚果糖(包括菊糖)。这种组合物最好含有低聚半乳糖和/或低聚果糖。
这种组合物优选设计成添加到专门的婴儿营养餐中。在本发明中的非消化低聚糖的累积重量，每餐优选在0.1-10g，更好是在0.2-5g。这种组合物较好是按每餐的量被包装起来，也就是说，按一餐的单位剂量包装起来，较好是以小袋的形式包装。每餐的这种组合物优选具有0.5-25g的干重，优选地1-10g。
应用
本发明提供了i)治疗和/或预防剖腹产分娩的婴儿疾病和/或ii)促进剖腹产分娩的婴儿的健康。尤其是那些由双歧杆菌菌群含量低而造成的肠道疾病。所述疾病优选地选自感染和过敏。本发明优选提供了预防和/或治疗感染和/或感染性疾病，尤其是肠与胃感染的方法，特别是治疗和/或预防那些由于一种或多种包括葡萄球菌(尤其是表皮葡萄球菌，金黄色葡萄球菌，溶血葡萄球菌)，链球菌(尤其是b族链球菌)，梭状芽孢杆菌(尤其是艰难梭菌)，芽孢杆菌(尤其是枯草芽孢杆菌)，假单胞菌(尤其是铜绿假单胞菌)，肠杆菌属，克雷伯菌属，不动杆菌，变形杆菌属，气单胞菌属和大肠杆菌属在内的微生物，尤其是大肠杆菌而引起的感染。本发明中的组合物优选用于治疗或预防剖腹产分娩的婴儿的肠道感染，尿路感染，肠炎和/或腹泻的方法中。本发明的组合物优选用于调节剖腹产婴儿免疫系统的方法，能较好地避免婴儿的过敏反应。
本发明的组合物较好是给予出生一年内的剖腹产分娩的婴儿，较好是在出生后的三个月，甚至更好是在出生后的两个星期之内，甚至更加好是在出生的后100个小时，更加好是在出生后的72个小时，最好的是在出生后的48小时之内。
本发明也同样提供了一种能够促进婴儿健康肠道菌群发育的方法，包括步骤A：将I)营养学上或者药学可接受的液体；和II)干燥的组合物混合，其中所述干燥的组合物II包含非消化低聚糖；和步骤B)将步骤A)中得到的组合物给予剖腹产分娩的婴儿。
给予本发明中的组合物能够导致改良的肠道菌群和/或由发酵微生物产生的代谢终产物有机酸的形成。有机酸量的增加能导致粘液产物的增加，促进肠道的成熟和/或增强的肠屏障。因此另一方面，本发明提供一种治疗和/或预防剖腹产分娩的婴儿过敏(尤其是食物过敏)，特应性湿疹(例如特应性皮炎)，哮喘，过敏性鼻炎，过敏性结膜炎的方法，上述的方法包括将包含本发明所述的非消化低聚糖(中性)的组合物给予婴儿。
并且，本发明组合物的给予能够增强免疫系统。另一方面，本发明能提供一种治疗和/或预防剖腹产分娩的婴儿的全身感染，耳炎和/或呼吸系统感染的方法。
具体实施例
实施例1：剖腹产分娩的婴儿和阴道分娩的婴儿的肠道微生态分子特征的对比
在本发明的研究中，通过利用特异性引物PCR扩增十种双歧杆菌种，瘤胃球菌和一种类杆菌种的方法来研究分娩方式(剖腹产相对于阴道分娩)对于出生后第三天肠道微生物成分的影响。
微生物的DNA提取和分析是根据Favier et al,Environ Microbiol 2002；68:219-226and Satokari et al,Appl Environ Microbiol 2001；67:504-513；Satorkari et al System Appl Microbiol 2003；26:572-584文章所提供的方法进行的。
表1中列出了在21个剖腹产分娩后第3天的婴儿的排泄物样品中检测的双歧杆菌和其他菌种。表2给出了在21个阴道分娩后第3天的婴儿的排泄物样品中检测的双歧杆菌和其他菌种。在剖腹产分娩的婴儿和那些阴道分娩的婴儿的排泄物中都没有发现齿双歧杆菌，角双歧杆菌，乳酸双歧杆菌，布氏瘤胃球菌，伶俐瘤胃球菌和卵瘤胃球菌菌种特殊的信号。
可以得出结论认为，剖腹产分娩的婴儿与阴道分娩的婴儿的所具有微生物菌群不同。剖腹产分娩的婴儿体内不仅双歧杆菌和其他菌种的数量少很多，而且比剖阴道分娩的婴儿的菌群的菌种种类水平也少很多。因为双歧杆菌在婴儿的体内菌群中是占主要的种类，这些结果也能被推广为剖腹产分娩的婴儿的体内较少的肠道菌群数量和种类，导致肠道更易被(医源性)病原菌侵害。
这些结果显示了本发明的组合物和方法的有益应用，例如：一种能够喂养剖腹产分娩婴儿，减少肠道内病原菌，促进肠道内健康菌群并且相应地预防感染，促进健康的免疫系统和消化道成熟的方法。
表1：剖腹产分娩的婴儿
(-)＝无扩增信号；(+/-)＝弱扩增信号；(+)＝阳性扩增信号；(++)＝强烈的扩增信号
表2：阴道分娩的婴儿
(-)＝无扩增信号；(+/-)＝弱扩增信号；(+)＝阳性扩增信号；(++)＝强烈的扩增信号
实施例2：非消化低聚糖对剖腹产分娩婴儿体内菌群的作用
婴儿被给予补充了0.8g/100ml平均聚合度为2-7的低聚半乳糖(GOS)和低聚果糖(FOS，Raftilin)的婴儿配方奶粉(GFSF组)，或被给予不含非消化低聚糖的标准的婴儿配方奶粉(SF组)。
在粪渣中双歧细菌的含量被测定。在第一周剖腹产分娩婴儿(数目n＝44)体内的所有双歧杆菌种类对于全部细菌的百分比是4.3％，相对于阴道分娩的婴儿(数目n＝28)是19.8％。在第6周，在剖腹产婴儿SF组(n＝21)中双歧杆菌的百分含量是12.3％，在剖腹产婴儿的GFSF组(N＝13)中双歧杆菌的百分含量是17.2％。剖腹产婴儿SF组粪便的pH值相对于剖腹产婴儿GFSF组是7.2比6.5。在剖腹产婴儿SF组中大肠杆菌的百分含量是11.8％，剖腹产婴儿GFSF组中大肠杆菌的百分含量是0％(见表3)。
这个结果显示了相对于不接受非消化中性低聚糖的剖腹产婴儿(SF组)，将非消化中性低聚糖给予剖腹产婴儿(GFSF组)可以导致更多的双歧因子菌群和减少潜在的病原菌的含量。并且结果显示由于非消化低聚糖的给予而减少了的大肠杆菌的含量。这个结果显示了本发明组合物中非消化低聚糖，尤其是低聚半乳糖和低聚果糖，进一步提高本发明对剖腹产婴儿的疗效的有益应用。
表3：阴道分娩的婴儿和喂养含有(GFSF)或不含有(SF)非消化低聚糖的配方奶粉的剖腹产婴儿体内双歧杆菌的百分含量
实施例3：非消化低聚糖的双歧因子的作用
婴儿被给予补充了0,8g/100ml具有平均聚合度为2-7的低聚半乳糖(GOS)和低聚果糖(FOS，Raftilin)的配方奶粉(GFSF组)，或者是被给予不含有非消化低聚糖的标准配方奶粉(SF组)。
粪便中的双歧杆菌的含量已经被测定。在出生后6周SF组和GFSF组中双歧杆菌种占总菌数的百分比分别是47％和68％，这表明喂养了非消化碳水化合物的混合物的GFSF组相对于SF组具有更多的双歧因子菌群。而且在种类水平上在GFSF组中婴儿双歧杆菌的百分比是22％，SF组中婴儿双歧杆菌的百分比是18％，GFSF组中长双歧杆菌的百分比是3.7％，SF组中长双歧杆菌的百分比是2.9％，GFSF组中短双歧杆菌的百分比是3.7％，SF组中短双歧杆菌的百分比是2.3％。这个结果显示了本发明组合物中非消化中性低聚糖，尤其是低聚半乳糖和低聚果糖，进一步地增强本发明对剖腹产婴儿的疗效的有益应用。
实施例4：给予剖腹产分娩的婴儿的组合物
一种婴儿配方奶粉组合物包含每100ml待喂食配方：1.6g蛋白质，3.6g脂肪，6.4g可消化的碳水化合物(主要是乳糖)，0.8g非消化的低聚糖，其中含有0.54g反式低聚半乳糖，0.06g菊糖，和0.2g果胶水解产物(水解酶水解柑橘类果胶制备而成的)。在这种配方组合物附随的包装和/或支撑物上可指明：这种配方组合物适合用于a)预防和/或治疗剖腹产婴儿感染；b)预防和/或治疗剖腹产婴儿大肠杆菌感染；c)预防和/或治疗剖腹产婴儿过敏；和/或d)调节免疫系统。
实施例5：喂养剖腹产分娩的婴儿的方法
小袋包装包括：
-0.2g糖醛酸低聚糖(约占干重的2wt.％)
-2g低聚半乳糖和0.3g低聚果糖(约占干重的20wt.％)
-短双歧杆菌和长双歧杆菌，每种菌株的滴度约5*109cfu；
-填充剂。

Claims (11)

1.组合物在制备用于治疗和/或预防剖腹产分娩的婴儿的病症的产品中的用途，其中所述病症选自过敏、哮喘、感染和特应性皮炎，所述组合物包含占其干重至少5wt.％的非消化低聚糖和选自长双歧杆菌，短双歧杆菌，婴儿双歧杆菌，链状双歧杆菌，假小链双歧杆菌，青春双歧杆菌，动物双歧杆菌，高卢双歧杆菌，乳双歧杆菌和分叉双歧杆菌的至少一种双歧杆菌菌种，其中所述非消化低聚糖的累积重量是0.1-10g/餐。
2.组合物在制备用于治疗和/或预防剖腹产分娩的婴儿的病症的产品中的用途，其中所述病症选自过敏、哮喘、感染和特应性皮炎，所述组合物包含(a)占其干重至少5wt.％的非消化低聚糖，(b)选自长双歧杆菌，短双歧杆菌，婴儿双歧杆菌，链状双歧杆菌，假小链双歧杆菌，青春双歧杆菌，动物双歧杆菌，高卢双歧杆菌，乳双歧杆菌和分叉双歧杆菌的至少一种双歧杆菌菌种和(c)5-100mg核苷酸/100g组合物干重。
3.如权利要求1所述的用途，其中所述非消化低聚糖是低聚半乳糖和/或低聚果糖。
4.如权利要求2所述的用途，其中所述非消化低聚糖是低聚半乳糖和/或低聚果糖。
5.如权利要求3所述的用途，其中所述非消化低聚糖包含低聚半乳糖和低聚果糖。
6.如权利要求4所述的用途，其中所述非消化低聚糖包含低聚半乳糖和低聚果糖。
7.如权利要求1-6中任一项所述的用途，其中所述组合物包含至少两种选自以下的双歧杆菌：长双歧杆菌，短双歧杆菌，婴儿双歧杆菌，链状双歧杆菌，假小链双歧杆菌和分叉双歧杆菌。
8.如权利要求1-6中任一项所述的用途，其中所述组合物至少包含短双歧杆菌。
9.如权利要求3-6中任一项所述的用途，其中所述低聚果糖包括菊糖。
10.如权利要求1-6中任一项所述的用途，其中所述组合物包长链多不饱和脂肪酸。
11.如权利要求1-4中任一项所述的用途，其中所述非消化低聚糖包括低聚半乳糖，并且所述组合物包含长链多不饱和脂肪酸。
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