TW201302205A - 預防急性呼吸道感染及/或緩解感染症狀之組合物 - Google Patents
預防急性呼吸道感染及/或緩解感染症狀之組合物 Download PDFInfo
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Abstract
本發明揭示一種組合物,其包含至少一種N-乙醯基乳糖胺、至少一種唾液酸基化寡醣及至少一種岩藻醣基化寡醣,該組合物用於預防急性呼吸感染(ARI)及/或緩解該等ARI感染之症狀。較佳地,該組合物係初生嬰兒配方(starter infant formula)。該急性呼吸感染具體而言係細枝氣管炎或耳炎。
Description
本發明係關於用於預防急性呼吸(道)感染(ARI)及/或緩解該ARI症狀之組合物。
呼吸道感染尤其在嬰兒及幼小兒童中很常見。例如,在生命之第1年中,嬰兒經常將經歷3次至6次該等感染。該等感染通常源於細菌且經常在諸如流行性感冒等病毒感染後發生。呼吸道之細菌感染之實例包括肺炎、細枝氣管炎、竇炎、咽炎及中耳炎。
急性呼吸感染(ARI)係繼發性細菌感染(與上呼吸道感染相反)。其可導致中耳感染、枝氣管炎、細枝氣管炎、肺炎、竇炎、咽炎、耳炎或鏈球菌喉炎。患有慢性肺病、氣喘、醣尿病或免疫系統減弱之人們更可能出現該等併發症。
頻繁之急性呼吸感染(ARI)通常與急性中耳炎相關。此係中耳感染,其中經由口連接中耳腔與外部環境之耳咽管(Eustachian tube)發炎且然後阻塞,從而將細菌封阻於中耳內部。在嚴重情形中,鼓膜可能會在壓力下破裂,從而允許感染液體到達內耳。此係潛在危險情況,若不進行治療其可導致聽力永久性受損。
急性中耳炎似乎與通常在鼻咽腔之固有微生物叢中發現之病原性細菌之活性有關。數量上,最重要病原體係肺炎鏈球菌(Streptococcus pneumoniae)(35%之病例)、無法歸類之流感嗜血菌(Haemophilus influenzae)(30%之病例)及黏膜炎莫拉氏菌(Moraxella catarrhalis)(10%之病例)。
50%之兒童會在其生命之第1年中至少發作一次急性中耳炎,且35%之兒童會在1歲與3歲之間反覆發作急性中耳炎。
細枝氣管炎係由影響通向肺之小氣道(稱為細枝氣管)之感染引起之另一常見呼吸道疾病。當該等氣道發炎時,其腫脹且充滿黏液,從而使呼吸困難。
儘管其通常係輕微疾病,但一些嬰兒具有感染需要住院之更嚴重疾病之風險。提高患嚴重細枝氣管炎之風險之病況包括早產、既往慢性心臟病或肺病及免疫系統由於疾病或用藥而減弱。
已患有細枝氣管炎之年幼兒童在以後之生活中可更可能出現氣喘,但人們並不清楚,該疾病是否引起或誘發氣喘,或最終出現氣喘之兒童是否僅比嬰兒更易出現細枝氣管炎。
細枝氣管炎通常係由病毒感染引起,該病毒感染一般而言係由於呼吸道融合性病毒(RSV)所致。RSV感染引起所有細枝氣管炎病例中之一半以上病例,且在冬季及初春傳播最廣。與細枝氣管炎有關之其他病毒包括鼻病毒、流行性感冒(流感)及人間質肺炎病毒。
自前述內容可看出,業內需要有效方法來預防ARI感染及/或緩解ARI之症狀,尤其係細枝氣管炎及急性中耳炎(或耳炎)。
人乳寡醣(HMO)共同係人乳中之第三大固體組份,位於乳糖及脂肪之後。HMO通常由還原端之乳糖及非還原端之碳水化合物核心(通常含有岩藻醣或唾液酸)組成。已分離且表徵大約100種乳寡醣,然而,該等寡醣僅佔其餘待表徵寡醣總數之極小部分。
在過去,出於不同目的使用HMO成份來研發嬰兒配方,例如岩藻醣基化寡醣、乳-N-四醣、乳-N-新四醣或唾液酸基化寡醣。
來自Abbott Laboratories之EP 0 975 235 B1闡述包含一或多種人乳寡醣之合成營養組合物,其中組合物中之HMO選自八種HMO(3-岩藻醣基乳糖、乳-N-岩藻五醣III、乳-N-岩藻五醣II、二岩藻醣基乳糖、2'-岩藻醣基乳糖、乳-N-岩藻五醣I、乳-N-新四醣及乳-N-岩藻五醣V)之群,其中該組合物意欲用於以下情形:正常健康嬰兒、兒童、成人或具有特殊需求之個體,例如彼等伴隨某些病理病況者。此歐洲專利陳述,一般而言,寡醣保護嬰兒免於呼吸道、胃腸道及泌尿-生殖道之病毒及細菌感染。
自前述內容可看出,業內需要有效營養組合物以尤其在嬰兒及年幼兒童中預防急性呼吸感染及/或緩解急性呼吸感染症狀,且其可便利並安全地投與。
業內需要在易感個體、尤其嬰兒且更具體而言呈現該等病況之病史或風險因素之嬰兒中緩和ARI、具體而言耳炎或細枝氣管炎之症狀及/或降低其嚴重性、頻率、發生率及/或持續時間。
業內需要干预以使得可保持該等虛弱個體之代謝平衡且因此不伴隨副作用,例如干擾免疫系統或改變發炎狀態。
業內需要藉由與虛弱個體(例如嬰兒或幼兒)相容且並非基於藥物之干预來改善通常與急性呼吸感染、具體而言耳炎及細枝氣管炎相關之症狀及緩和與其相關之病況。該等病況可包括對睡眠品質及/或數量、疼痛、活動過多或活動減少及/或哭泣時間之影響。
本發明者已驚奇地發現,包含特定人類寡醣之混合物之組合物尤其有效地用於預防急性呼吸感染(ARI)及/或緩解急性呼吸感染之症狀,且具體而言預防細枝氣管炎或耳炎及/或緩解其症狀。
因此,本發明提供組合物,其包含至少一種N-乙醯基乳糖胺、至少一種唾液酸基化寡醣及至少一種岩藻醣基化寡醣,該組合物用於預防急性呼吸感染及/或緩解急性呼吸感染之症狀。
本文中所用之以下術語具有以下含義。
術語「嬰兒」意指年齡在12個月以內之兒童。
術語「年幼兒童」意指年齡介於1歲與3歲之間之兒童。
術語「嬰兒配方」意指意欲用於在生命之最初4個月至6個月期間之嬰兒之特定營養用途且本身滿足此類人之營養要求之食品(1991年5月14日關於嬰兒配方及較大嬰兒配方(follow-on formulae)之歐洲委員會指令(European Commission Directive) 91/321/EEC第1.2條)。
術語「較大嬰兒配方」意指意欲用於年齡超過4個月之嬰兒之特定營養用途且構成此類人逐漸多樣化之飲食中之主要液體要素之食品。
術語「初生嬰兒配方(starter infant formula)」意指用於在生命之最初4個月期間之嬰兒之特定營養用途之食品。
術語「幼兒食物」意指意欲用於在生命第1年期間之嬰兒之特定營養用途之食品。
術語「嬰兒穀類組合物」意指意欲用於在生命第1年期間之嬰兒之特定營養用途之食品。
術語「成長乳」意指適應年幼兒童之特定營養需求之基於乳之飲品。
術語「離乳期」意指藉由嬰兒飲食中之其他食物替代母乳之階段。
術語「預防ARI」意指預防ARI、具體而言耳炎及細枝氣管炎及降低其頻率及/或發生率及/或嚴重性及/或持續時間。發生率係指任何ARI之數量。頻率係指同一ARI之數量。此預防涵蓋降低該ARI在以後之生活中之頻率及/或嚴重性。術語「在以後之生活中」涵蓋干预終止後之效應。「在以後之生活中」之效應較佳可係該干預終止後2週至4週、2個月至12個月或2年至12年(例如,2年、5年、10年)。
術語「緩解ARI症狀」意指減少患有ARI之嬰兒及年幼兒童之ARI症狀、尤其細枝氣管炎或耳炎之症狀,且具體而言使其呼吸過程舒適及/或減輕其疼痛及/或使其睡眠舒適及/或穩定其活動。
術語「營養組合物」意指給予個體營養之組合物。此營養組合物通常係口服或靜脈內服用,且其通常包括脂質或脂肪來源及蛋白質來源。
術語「合成混合物」意指藉由化學及/或生物方式獲得之混合物,其可在化學上與哺乳動物乳中天然存在之混合物相同。
術語「低致敏性營養組合物」意指不太可能引起過敏反應之營養組合物。
術語「唾液酸基化寡醣」意指具有唾液酸殘基之寡醣。
術語「岩藻醣基化寡醣」意指具有岩藻醣殘基之寡醣。
術語「益菌生」意指不可消化性碳水化合物,其藉由選擇性刺激人類結腸中之健康細菌(例如雙歧桿菌(bifidobacteria))之生長及/或活性來有益地影響宿主(Gibson GR,Roberfroid MB.Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995;125: 1401-12)。
術語「益生菌」意指對宿主之健康或身體狀況具有有益效應之微生物細胞製劑或微生物細胞組份(Salminen S、Ouwehand A. Benno Y.等人,「Probiotics: how should they be defined」Trends Food Sci. Technol. 1999: 10 107-10)。
「過敏」係已由內科醫師檢測到並可以不定時方式或以更持久方式治療之過敏。
除非另有說明,否則所有百分比均以重量計。
本發明組合物較佳係低致敏性組合物。
該組合物含有至少一種N-乙醯基-乳糖胺。換言之,其含有N-乙醯基-乳糖胺及/或含有N-乙醯基-乳糖胺之寡醣。含有N-乙醯基-乳糖胺之適宜寡醣包括乳-N-四醣(LNT)及乳-N-新四醣(LNnT)。
因此,根據本發明,N-乙醯基-乳糖胺較佳選自包含乳-N-四醣(LNT)及乳-N-新四醣(LNnT)之群。
如(例如)在美國專利第5,288,637號及WO 96/10086中所闡述,LNT及LNnT可藉由使用醣基轉移酶將醣類單元自供體部分酶促轉移至受體部分來化學合成。另一選擇為,如在Wrodnigg,T.M.;Stutz,A.E.(1999) Angew. Chem. Int. Ed. 38:827-828中所闡述,LNT及LNnT可藉由將游離或結合至寡醣(例如,乳酮醣)之酮-己醣(例如,果醣)化學轉化為N-乙醯基己醣胺或含N-乙醯基己醣胺之寡醣來製備。然後可將以此方式產生之N-乙醯基-乳糖胺轉移至作為受體部分之乳糖。
較佳地,本發明組合物以乾重計含有0.1 g至3 g N-乙醯基-乳糖胺乳糖/100 g組合物。
根據本發明,唾液酸基化寡醣選自包含3'-唾液酸基乳糖及6'-唾液酸基乳糖之群。較佳地,3'-唾液酸基乳糖及6'-唾液酸基乳糖二者均存在於該組合物中。在此實施例中,3'-唾液酸基乳糖與6'-唾液酸基乳糖之間之比率較佳在介於5:1與1:2之間之範圍內。
3'-及6'-形式之唾液酸基乳糖可藉由層析或過濾技術自天然來源(例如動物乳)分離。另一選擇為,其可藉由生物技術方法使用特定唾液酸基轉移酶或唾液酸酶(神經胺酸酶)藉由基於酶之發酵技術(重組或天然酶)、藉由化學合成或藉由微生物發酵技術來產生。在後一情形中,微生物可表現其天然酶及受質或可經改造以產生各別受質及酶。可使用單一微生物培養物或混合培養物。可由受體受質自聚合度(DP)=1往前之任一聚合度為起點開始形成唾液酸基寡醣。另一選擇為,唾液酸基乳糖可藉由化學合成自乳糖及游離N'-乙醯基神經胺酸(唾液酸)來產生。唾液酸基乳糖亦可購自(例如)Kyowa Hakko Kogyo(日本)。
較佳地,本發明組合物以乾重計含有0.05 g至2 g、更佳0.1 g至2 g之唾液酸基化寡醣/100 g組合物。
岩藻醣基化寡醣可選自包含以下之群:2'-岩藻醣基乳糖、3-岩藻醣基乳糖、二岩藻醣基乳糖、乳-N-岩藻五醣(換言之,乳-N-岩藻五醣I、乳-N-岩藻五醣II、乳-N-岩藻五醣III及乳-N-岩藻五醣V)、乳-N-二岩藻六醣I、岩藻醣基乳-N-六醣、二岩藻醣基乳-N-六醣I及二岩藻醣基乳-N-新六醣II。尤佳岩藻醣基化寡醣係2'-岩藻醣基乳糖(2 FL)。
岩藻醣基化寡醣可藉由層析或過濾技術自天然來源(例如動物乳)分離。另一選擇為,其可藉由生物技術方法使用特定岩藻醣基轉移酶及/或岩藻醣苷酶經由使用基於酶之發酵技術(重組或天然酶)或微生物發酵技術來產生。在後一情形中,微生物可表現其天然酶及受質或可經改造以產生各別受質及酶。可使用單一微生物培養物及/或混合培養物。可由受體受質自聚合度(DP)=1往前之任一聚合度為起點開始形成岩藻醣基化寡醣。另一選擇為,岩藻醣基化寡醣可藉由化學合成自乳糖及游離岩藻醣產生。岩藻醣基化寡醣亦可購自(例如)Kyowa,Hakko,Kogyo(日本)。
較佳地,本發明組合物以乾重計含有0.1 g至3 g岩藻醣基化寡醣/100 g組合物。
在較佳實施例中,本發明組合物包含總量為0.05 g至3 g N-乙醯基化乳糖胺、唾液酸基化寡醣及岩藻醣基化寡醣/100 g組合物。
本發明組合物可進一步包含至少一種益生菌菌株,該益生菌菌株較佳係雙歧桿菌及/或乳酸桿菌(Lactobacilli)。
適宜益生菌菌株包括以商標LGG得自Valio Oy(芬蘭)之鼠李醣乳酸桿菌(Lactobacillus rhamnosus) ATCC 53103、鼠李醣乳酸桿菌CGMCC 1.3724、類乾酪乳酸桿菌(Lactobacillus paracasei)CNCM I-2116、由BioGaia A.B以商標Reuteri出售之路氏乳酸桿菌(Lactobacillus reuteri)、約氏乳酸桿菌(Lactobacillus johnsonii) CNCM I-1225、由BLIS Technologies有限公司(紐西蘭)以名稱KI2出售之唾液鏈球菌(Streptococcus salivarius)DSM 13084、尤其由Christian Hansen公司(丹麥)以商標Bb 12出售之乳酸雙歧桿菌(Bifidobacterium lactis) CNCM 1-3446、由Morinaga Milk Industry有限公司(日本)以商標BB536出售之長雙歧桿菌(Bifidobacterium longum)ATCC BAA-999、由Danisco以商標Bb-03出售之短雙歧桿菌(Bifidobacterium breve)、由Morinaga以商標M-16V出售之短雙歧桿菌、由Procter & GambIe公司以商標Bifantis出售之嬰兒雙歧桿菌(Bifidobacterium infantis)及由Institut Rosell(Lallemand)以商標R0070出售之短雙歧桿菌。
較佳地,本發明組合物以乾重計含有10e3 cfu至10e12 cfu、更佳10e7 cfu至10e12 cfu之益生菌菌株/g組合物。
本發明組合物可進一步包含至少一種益菌生,其量通常介於0.3重量%與10重量%組合物之間。
益菌生通常不在胃或小腸中分解並吸收,且因此其在進入結腸時保持完整,其在結腸中經有益細菌選擇性發酵,在此意義上,其係不可消化的。益菌生之實例包括某些寡醣,例如果寡醣(FOS)及半乳寡醣(GOS)。可使用益菌生之組合,例如90% GOS與10%短鏈果寡醣(例如在BENEO-Orafti以商標Orafti寡果醣(先前係Raftilose)出售之產品中)或10%菊醣(例如BENEO-Orafti以商標Orafti菊醣(先前係Raftiline)出售之產品中)之組合。益菌生之尤佳組合係70%短鏈果寡醣及30%菊醣,其係由BENEO-Orafti以商標「Prebio 1」出售之產品。
本發明組合物可進一步包含至少一種較佳針對病原性鏈球菌(Streptococci)、嗜血菌、莫拉氏菌、葡萄球菌(Staphylococci)之噬菌體(細菌病毒)或噬菌體混合物。
本發明組合物較佳係合成營養組合物。在此情形中,其可係初生嬰兒配方、嬰兒配方、幼兒食物、嬰兒穀類組合物、較大嬰兒配方或成長乳,且該組合物較佳係初生嬰兒配方。
根據較佳實施例,本發明組合物用於患有ARI之嬰兒及年幼兒童。
本發明組合物可在離乳期之前及/或期間使用。
本發明組合物可進一步包含至少一種針對(例如)病原性鏈球菌、嗜血菌、莫拉氏菌、葡萄球菌之噬菌體或噬菌體混合物。
因此,本發明組合物較佳在患有ARI或具有ARI之早期症狀之嬰兒中用於使呼吸過程舒適、減輕疼痛、使睡眠舒適及/或緩解症狀。
ARI具體而言係細枝氣管炎或耳炎。
本發明亦包括包含至少一種N-乙醯基乳糖胺、至少一種唾液酸基化寡醣及至少一種岩藻醣基化寡醣之組合物作為合成營養劑之用途,其用於預防及/或治療急性呼吸感染、較佳細枝氣管炎或耳炎。
此用途涵蓋組合物係較佳以單位劑量形式提供之補充品之情形。
上文所述所有用途尤其意欲用於嬰兒及年幼兒童。本發明之組合物及用途尤其適於具有呼吸道感染及/或發炎風險、具有呼吸道感染或發炎家族史或已經歷數次呼吸道感染或發炎(及/或呼吸過敏)發作之嬰兒及兒童。在一實施例中,本發明之組合物及用途適合於具有呼吸道感染或發炎風險或已經歷呼吸道感染或發炎(及/或呼吸過敏)發作之青少年或成人。
不希望受理論限制,本發明者認為,上文所述寡醣之組合在預防ARI及/或緩解ARI症狀中之效力可係藉由上文所述寡醣之組合誘發之事件之協同相互作用的結果。一方面促進共生口咽微生物叢,且另一方面抑制潛在病原性微生物。例如,眾所周知,特定可溶性乳寡醣(參見上文)可減緩多種口咽病原體之附著。人們認為此促進與抑制之組合導致確立具有最優且平衡之(i)生態區位佔有、(ii)微生物叢-宿主相互作用及(iii)生態穩定性之口咽微生物叢。此意味著,(i)即使在外源非生物性及生物性刺激後仍可維持穩定口咽生態平衡。因此,在干預期之後潛在感染因子仍受抑制且不能容易地確立並引起ARI疾病。
寡醣可在相同組合物中投與或可依序投與。
若欲用於0至12個月生命之年齡組,則組合物較佳係以液體形式食用之營養組合物。其可係營養完整配方,例如嬰兒配方、較大嬰兒配方或成長乳。對於年幼兒童組而言,另一選擇為,組合物可係(例如)汁液飲料或其他冷凍或常溫保存(shelf stable)飲品或湯,或幼兒食物或嬰兒穀類組合物。
本發明組合物亦含有蛋白質來源,其量較佳低於2.0 g/100 kcal,其量甚至更佳低於1.8 g/100 kcal。人們相信,蛋白質類型對本發明無關鍵作用,前提係滿足對於必需胺基酸之最基本要求且確保良好生長。因此,可使用基於乳清、酪蛋白及其混合物之蛋白質來源以及基於大豆之蛋白質來源。就乳清蛋白質而言,蛋白質來源可基於酸乳清或甜乳清或其混合物且可以任何期望比例包括α-乳白蛋白及β-乳球蛋白。
蛋白質可係完整蛋白質或水解蛋白質或完整蛋白質與水解蛋白質之混合物。對於(例如)認為具有出現牛乳過敏風險之嬰兒,可期望供應部分水解蛋白質(水解度介於2%與20%之間)。一般而言,水解蛋白質可降低過敏(對牛乳或對其他過敏原)之風險。由於需要水解蛋白質,故可根據需要並如業內所熟知來實施水解製程。例如,乳清蛋白質水解產物可藉由在一或多個步驟中酶促水解乳清部分來製備。若用作起始材料之乳清部分實質上不含乳糖時,則發現在水解製程期間之蛋白質顯然較不會受到離胺酸封阻。此使離胺酸封阻程度可自約15重量%之總離胺酸降低至小於約10重量%之離胺酸,例如約7重量%之離胺酸,此顯著改善蛋白質來源之營養品質。
本發明組合物通常含有碳水化合物來源。此在本發明營養組合物係嬰兒配方之情形中尤佳。在此情形中,儘管較佳碳水化合物來源係乳糖,但仍可使用嬰兒配方中常用之任一碳水化合物來源,例如乳糖、蔗醣、麥芽糊精、澱粉及其混合物。
本發明組合物通常含有脂質來源。若本發明營養組合物係嬰兒配方,則此尤其適當。在此情形中,脂質來源可係適用於嬰兒配方之任一脂質或脂肪。較佳脂肪來源包括棕櫚油酸、高油酸向日葵油及高油酸紅花油。亦可添加必需脂肪酸亞麻油酸及α-次亞麻油酸,亦可添加少量含有大量預形成花生四烯酸及二十二碳六烯酸之油,例如魚油或微生物油。脂肪來源之n-6與n-3脂肪酸之比率較佳為約5:1至約15:1;例如約8:1至約10:1。
本發明之營養組合物亦較佳以營養顯著量含有認為在日常飲食中所必需之所有維生素及礦物質。已確立對某些維生素及礦物之最基本要求。本發明組合物中視情況存在之礦物、維生素及其他營養素之實例包括維生素A、維生素B1、維生素B2、維生素B6、維生素B12、維生素E、維生素K、維生素C、維生素D、葉酸、肌醇、菸鹼酸、生物素、泛酸、膽鹼、鈣、磷、碘、鐵、鎂、銅、鋅、錳、氯、鉀、鈉、硒、鉻、鉬、牛磺酸及L-肉鹼。礦物通常以鹽形式添加。特定礦物及其他維生素之存在及量將視既定群體而變化。
若需要,則本發明組合物可含有乳化劑及穩定劑,例如大豆卵磷酯、單-及二甘油脂之檸檬酸酯及諸如此類。
本發明組合物亦可含有可能具有有益效應之其他物質,例如乳鐵蛋白、核苷酸、核苷及諸如此類。
現在藉助實例闡述本發明組合物。
配方可以任一適宜方式製備。例如,其可藉由以合適比例將蛋白質、碳水化合物來源及脂肪來源摻和在一起來製備。若使用,則乳化劑可於此時納入。維生素及礦物可於此時添加,但其通常在稍後添加以避免熱降解。可在摻和前將任何親脂性維生素、乳化劑及諸如此類溶解於脂肪來源中。然後可混入水(較佳為經過逆滲透之水)以形成液體混合物。水溫便利地在介於約50℃與約80℃之間之範圍內以幫助成份之分散。可使用市售液化劑來形成液體混合物。若欲使最後產物具有液體形式,則將於此階段添加N-乙醯基-乳糖胺、唾液酸基化寡醣及岩藻醣基化寡醣。若欲使最後產物為粉末,則若需要亦可在此階段添加該等寡醣。然後在(例如)兩個階段中將液體混合物均質化。
然後,可藉由(例如)將液體混合物迅速加熱至介於約80℃與約150℃之間之範圍內之溫度並保持介於約5秒與約5分鐘之間之持續時間,來熱處理液體混合物以降低細菌載量。此可藉助蒸汽注入、高壓釜或熱交換器(例如,板式熱交換器)來實施。
然後,可藉由(例如)急驟冷卻將液體混合物冷卻至約60℃與約85℃之間。然後,可在(例如)兩個階段中再次將液體混合物均質化,在第一階段中介於約10 Mpa與約30 Mpa之間,且在第二階段中介於約2 Mpa與約10 Mpa之間。然後,可進一步冷卻均質化混合物以添加任何熱敏感性組份,例如維生素及礦物質。宜在此時調整均質化混合物之pH及固體含量。
將均質化混合物轉移至適宜乾燥裝置(例如,噴霧乾燥器或冷凍乾燥器)中並轉化為粉末。粉末之水分含量應小於約5重量%。N-乙醯基-乳糖胺、唾液酸基化寡醣及岩藻醣基化寡醣可在此階段藉由與益生菌菌株(若使用)一起乾燥混合後添加,或由其以晶體糖漿形式與益生菌菌株(若使用)一起摻和並噴霧乾燥(或冷凍乾燥)後添加。
若液體組合物較佳,則可將均質化混合物滅菌然後無菌填充至適宜容器中,或可首先將其填充至容器中且然後經滅菌釜處理。
在另一實施例中,本發明組合物可係補充品,其以足以在個體中達成期望效應之量包括N-乙醯基-乳糖胺、唾液酸基化寡醣及岩藻醣基化寡醣。此投與形式更適於較年長兒童及成人。較佳地,N-乙醯基-乳糖胺之日劑量係0.1 g至3 g,唾液酸基化寡醣之日劑量係0.1 g至2 g,且岩藻醣基化寡醣之日劑量係0.1 g至3 g。
將根據欲投與補充品之方式來選擇欲包括於補充品中之寡醣之量。例如,若欲一天兩次投與補充品,則每份補充品可含有0.05 g至1.5 g之N-乙醯基-乳糖胺、0.05 g至1 g之唾液酸基化寡醣及0.05 g至1.5 g之岩藻醣基化寡醣。
補充品可呈(例如)錠劑、膠囊、軟錠或液體之形式。補充品可進一步含有保護性水膠體(例如膠、蛋白質、改質澱粉)、黏合劑、膜形成劑、囊封劑/材料、壁/殼材料、基質化合物、包衣、乳化劑、表面活性劑、增溶劑(油、脂肪、蠟、卵磷脂等)、吸附劑、載劑、填充劑、共化合物、分散劑、潤濕劑、處理助劑(溶劑)、流動劑、遮味劑、增重劑、膠凝劑(jellifying agent)及凝膠形成劑。補充品亦可含有習用醫藥添加劑及佐劑、賦形劑及稀釋劑,包括(但不限於)水、任何來源之明膠、植物膠、磺酸木質素、滑石、醣、澱粉、阿拉伯膠(gum arabic)、植物油、聚伸烷基二醇、矯味劑、防腐劑、穩定劑、乳化劑、緩衝劑、潤滑劑、著色劑、潤濕劑、填充劑及諸如此類。
另外,依照諸如USRDA等政府機構之推薦,補充品可含有適於口服或非經腸投與之有機或無機載劑材料以及維生素、痕量礦物元素及其他微量營養素。
本發明嬰兒配方之組合物之實例於下文給出。此組合物僅以說明方式給出。另一實例基於市售NAN及或Lactogen嬰兒配方(來自Nestl,瑞士),以下文所述量向其添加本發明特定寡醣。
已結合本發明實施以下實驗研究(研究模型1及2)。
下文概述之發現顯示,特定寡醣摻合物促進乳酸菌(長雙歧桿菌嬰兒亞種,Bifidobacterium longum subsp infantis)之代謝活性,從而增強對模型病原體之抑制。在嬰兒中,母乳中較大量之寡醣摻合物與較少之呼吸感染相關。
多個結果一起顯示,特定寡醣摻合物與特定嬰兒共生細菌協同作用,減少呼吸感染。
使長雙歧桿菌嬰兒亞種(ATCC15697)在API生長培養基中厭氧生長,該API生長培養基補充有1%(w/v)葡萄糖或1%(w/v) 2'岩藻醣基乳糖(2FL)或1%(w/v)乳-N-新四醣(LNnT)或1%(w/v) 6'唾液酸基乳糖(6SL)或1%(w/v)之等量2FL、LNnT及6SL之組合。稀釋各過夜培養物,使其在含有0.1%葡萄糖作為碳源之DMEM(杜貝克氏改良伊氏培養基,Dulbeccos modified Eagle Medium)中之初始OD600為0.1。所用此培養基不含任何其他碳水化合物補充品或具有額外之1%(w/v)葡萄糖或1%(w/v) 2'岩藻醣基乳糖(2FL)或1%(w/v)乳-N-新四醣(LNnT)或1%(w/v) 6'唾液酸基乳糖(6SL)或1%(w/v)之等量2FL、LNnT及6SL之組合。依此方式在37℃厭氧條件下調整DMEM培養基之條件。
再培育一夜之後,使條件培養基離心且經由0.22微米過濾器過濾上清液以移除細菌。藉由HPLC使用Hi-Plex H管柱及UV檢測器來定量乙酸鹽。
因此,使用NaOH將條件DMEM培養基調整至約6至7之pH,並將其與10e6 cfu/ml之過夜生長之模型病原體(鼠傷寒沙門氏菌SL1344,Salmonella typhimurium SL1344)一起培育。在37℃下培育2小時之後,將其塗覆於LB瓊脂上並在37℃下培育過夜,然後量化病原體。
圖1圖解說明實驗結果,其顯示雙歧桿菌(長雙歧桿菌嬰兒亞種)在不含額外碳水化合物或具有以下額外物質之DMEM培養基中之代謝刺激:葡萄糖(Glc)或乳-N-新四醣(LNnT)或2'岩藻醣基乳糖(2FL)或6'唾液酸基乳糖(6SL)或LNnT、6SL及2FL之摻合物。(n=6;顯示帶有SEM之平均值;指明ANOVA顯著性)。注意:僅LNnT、6SL及2FL之摻合物顯著刺激乙酸鹽之產生。
圖2圖解說明實驗結果,其顯示雙歧桿菌(長雙歧桿菌嬰兒亞種)在不含額外碳水化合物或具有以下額外物質之培養基中之活體外生長:葡萄糖(Glc)或乳-N-新四醣(LNnT)或2'岩藻醣基乳糖(2FL)或6'唾液酸基乳糖(6SL)或LNnT、6SL及2FL之摻合物。(n=4;顯示帶有SEM之平均值;藉由小寫字母指明ANOVA顯著性(p<0.01))。
已驚奇地發現,由等份之岩藻醣基化寡醣(例如,2'FL)、N-乙醯基化寡醣(例如,LNnT)及唾液酸基化寡醣(例如,6SL)組成之寡醣摻合物顯著提高乳酸菌(例如,雙歧桿菌)之代謝活性,如藉由乙酸鹽之形成可見(圖1)。
另外,與經個別寡醣或單獨之葡萄糖條件化之培養基相比,經雙歧桿菌及所提及寡醣摻合物條件化之培養基亦顯著且協同地抑制模型病原體(圖2)。
現今尚未得知抑制功能之確切性質,但吾人認為,2FL、LNNT及6SL之寡醣摻合物與雙歧桿菌協同作用以發揮超過此處在活體外測試之模型病原體之抗病原效應。
自約270個嬰兒母親對之隊列分析早期乳樣品中存在之特定寡醣之量。為此,將脫脂乳樣品在水中稀釋10倍至100倍,並藉由配備有CarboPac PA1管柱(Dionex)及電化學檢測器之HPAEC(Dionex)來分析。利用可靠寡醣標準品實施寡醣鑑別及量化。對餵養(i)具有少量(低於2 g/l)及(ii)具有大量(超過2 g/l)寡醣摻合物(由2FL、LNnT及6SL組成)之乳之嬰兒中呼吸感染次數作圖。
圖3圖解說明實驗結果,其顯示餵養含有少量(<2 g/l)或大量( 2g/l)由2FL、LNnT及6SL組成之寡醣摻合物之乳之嬰兒直至2歲時的呼吸感染次數。(指明統計顯著性)。
驚奇地發現,在用含有較大量寡醣摻合物之乳餵養之嬰兒中,呼吸感染次數顯著降低。
Claims (14)
- 一種組合物,其包含至少一種N-乙醯基乳糖胺、至少一種唾液酸基化寡醣及至少一種岩藻醣基化寡醣,該組合物用於預防急性呼吸感染及/或緩解急性呼吸感染之症狀。
- 如請求項1之組合物,其中該N-乙醯基-乳糖胺選自包含乳-N-四醣及乳-N-新四醣之群。
- 如請求項1之組合物,其中該唾液酸基化寡醣選自包含3'-唾液酸基乳糖及6'-唾液酸基乳糖之群,且該組合物較佳包含3'-唾液酸基乳糖及6'-唾液酸基乳糖二者,3'-唾液酸基乳糖與6'-唾液酸基乳糖之間之比率較佳在介於5:1與1:2之間之範圍內。
- 如請求項1之組合物,其中該岩藻醣基化寡醣選自包含以下之群:2'-岩藻醣基乳糖、3-岩藻醣基乳糖、二岩藻醣基乳糖、乳-N-岩藻五醣(換言之,乳-N-岩藻五醣I、乳-N-岩藻五醣II、乳-N-岩藻五醣III及乳-N-岩藻五醣V)、乳-N-二岩藻六醣I、岩藻醣基乳-N-六醣、二岩藻醣基乳-N-六醣I及二岩藻醣基乳-N-新六醣II,且該岩藻醣基化寡醣較佳係2'-岩藻醣基乳糖(2-FL)。
- 如請求項1至4中任一項之組合物,其中該組合物進一步包含至少一種益生菌菌株,該益生菌菌株較佳係雙歧桿菌(Bifidobacteria)及/或乳酸桿菌(Lactobacilli)。
- 如請求項1至4中任一項之組合物,其中該組合物進一步包含至少一種益菌生。
- 如請求項1至4中任一項之組合物,其中該組合物進一步包含至少一種噬菌體或噬菌體混合物。
- 如請求項1至4中任一項之組合物,其中該組合物係初生嬰兒配方(starter infant formula)、嬰兒配方、較大嬰兒配方(follow-on formula)、幼兒食物配方、嬰兒穀類配方或成長乳,且該組合物較佳係初生嬰兒配方。
- 如請求項1至4中任一項之組合物,其用於患有急性呼吸感染之嬰兒及年幼兒童。
- 如請求項1至4中任一項之組合物,其在離乳期之前及/或期間使用。
- 如請求項1至4中任一項之組合物,其在患有ARI或具有ARI之早期症狀之嬰兒中用於使呼吸過程舒適、減輕疼痛、使睡眠舒適及/或緩解症狀。
- 一種組合物之用途,該組合物包含至少一種N-乙醯基乳糖胺、至少一種唾液酸基化寡醣及至少一種岩藻醣基化寡醣,該組合物用於製造合成營養劑,該合成營養劑用於預防及/或治療急性呼吸感染、較佳係細枝氣管炎或耳炎。
- 如請求項12之用途,其中該組合物係較佳以單位劑量形式提供之補充品。
- 如請求項1至4中任一項之組合物,其中該組合物包含水解及/或部分水解蛋白質,較佳包含足量或例如可降低過敏風險之量。
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TW100142957A TW201302205A (zh) | 2010-11-23 | 2011-11-23 | 預防急性呼吸道感染及/或緩解感染症狀之組合物 |
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US (1) | US9763465B2 (zh) |
EP (2) | EP2465509A1 (zh) |
CN (1) | CN103582485A (zh) |
AU (1) | AU2011340882B2 (zh) |
BR (1) | BR112013012598A2 (zh) |
CA (1) | CA2818012A1 (zh) |
CL (1) | CL2013001433A1 (zh) |
IL (1) | IL226348A0 (zh) |
MX (1) | MX343321B (zh) |
RU (1) | RU2593321C2 (zh) |
SG (1) | SG190323A1 (zh) |
TW (1) | TW201302205A (zh) |
WO (1) | WO2012076323A1 (zh) |
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BR112013016905A2 (pt) | 2010-12-31 | 2019-09-24 | Abbott Lab | métodos para diminuir incidência de enterocolite necrosante em bebês, crianças pequenas, ou crianças usando oligossacarídeos do leite humano |
WO2012092153A1 (en) | 2010-12-31 | 2012-07-05 | Abbott Laboratories | Nutritional compositions comprising human milk oligosaccharides and nucleotides and uses thereof for treating and/or preventing enteric viral infection |
EP2658548B1 (en) | 2010-12-31 | 2018-02-21 | Abbott Laboratories | Human milk oligosaccharides for modulating inflammation |
EP3473257A1 (en) | 2010-12-31 | 2019-04-24 | Abbott Laboratories | Methods of using human milk oligosaccharides for improving airway respiratory health |
MY174542A (en) | 2010-12-31 | 2020-04-24 | Abbott Lab | Human milk oligosaccharides to promote growth of beneficial bacteria |
SG191799A1 (en) | 2010-12-31 | 2013-08-30 | Abbott Lab | Nutritional formulations including human milk oligosaccharides and long chain polyunsaturated polyunsaturated fatty acids and uses thereof |
MY180910A (en) | 2010-12-31 | 2020-12-11 | Abbott Lab | Methods for reducing the incidence of oxidative stress using human milk oligosaccharides, vitamin c and anti-inflammatory agents |
ES2657744T3 (es) | 2011-07-22 | 2018-03-06 | Abbott Laboratories | Galactoligosacáridos para prevenir lesiones y/o promover la curación del tracto gastrointestinal |
CN104023560A (zh) | 2011-08-29 | 2014-09-03 | 雅培制药有限公司 | 用于预防胃肠道损伤和/或促进胃肠道愈合的人乳寡糖 |
EP2745705A1 (en) * | 2012-12-18 | 2014-06-25 | Abbott Laboratories | Nutritional use of human milk oligosaccharides |
US20150050245A1 (en) * | 2013-08-14 | 2015-02-19 | Tntgamble, Inc. | Methods and delivery system for beneficial additive and subtractive biological agents to promote balanced mammalian gastrointestinal flora |
AU2014350419B2 (en) * | 2013-11-15 | 2019-10-24 | Société des Produits Nestlé S.A. | Compositions for preventing or treating allergies in infants from or fed by non secretor mothers by providing fucosylated-oligosaccharides in particular among infants at risk or born by C-section |
ES2857077T3 (es) * | 2013-11-15 | 2021-09-28 | Nestle Sa | Composiciones para su uso en la prevención o tratamiento de infecciones del TRS en bebés o niños jóvenes en riesgo |
MX2017005260A (es) | 2014-10-24 | 2018-01-30 | Evolve Biosystems Inc | Bifidobacterias activadas y metodos de uso de las mismas. |
RU2720933C2 (ru) * | 2014-10-31 | 2020-05-14 | Сосьете Де Продюи Нестле С.А. | Композиция, содержащая fut2-зависимые олигосахариды и лакто-n-неотетраозу, для применения с целью активации развития головного мозга и познавательной способности |
US10881674B2 (en) | 2014-12-08 | 2021-01-05 | Glycom A/S | Synthetic composition for treating metabolic disorders |
EP3229812A4 (en) | 2014-12-08 | 2018-10-03 | Glycom A/S | Synthetic composition for treating metabolic disorders |
US10835544B2 (en) | 2014-12-08 | 2020-11-17 | Glycom A/S | Synthetic composition for regulating satiety |
US10987368B2 (en) | 2014-12-08 | 2021-04-27 | Glycom A/S | Synthetic composition for preventing or treating CVD |
RU2020107846A (ru) * | 2015-03-05 | 2020-03-16 | Сосьете Де Продюи Нестле С.А. | Композиции для применения в профилактике или лечении отита или бронхита у младенцев или детей младшего возраста |
CN107405354A (zh) * | 2015-03-05 | 2017-11-28 | 格礼卡姆股份公司 | 治疗急性呼吸道感染的组合物和方法 |
MX2017010923A (es) * | 2015-03-05 | 2018-01-16 | Nestec Sa | Composiciones para usar en el mejoramiento de la consistencia o la frecuencia de las heces en infantes o niños pequeños. |
US11957148B2 (en) * | 2015-12-15 | 2024-04-16 | Societe Des Produits Nestle S.A. | Mixture of human milk oligosaccharides(HMOs) |
CN105725216A (zh) * | 2016-03-15 | 2016-07-06 | 天津普生源科技发展有限公司 | 一种含有gaba的助眠功能食品及其制备方法 |
WO2018020473A1 (en) | 2016-07-28 | 2018-02-01 | Fonterra Co-Operative Group Limited | Dairy product and process |
AU2017324759B2 (en) * | 2016-09-07 | 2022-07-28 | Société des Produits Nestlé S.A. | Nutritional compositions for infants and/or young children comprising oligosaccharides |
EP3629767A1 (en) | 2017-05-24 | 2020-04-08 | Société des Produits Nestlé S.A. | Hmos blends for use in infants or young children for health purposes |
CN109043542A (zh) * | 2018-09-11 | 2018-12-21 | 内蒙古伊利实业集团股份有限公司 | 人乳寡糖和/或其前体在制备预防儿童龋齿疾病的组合物中的应用 |
CN113423288A (zh) * | 2019-02-04 | 2021-09-21 | N·V·努特里奇亚 | 用于睡眠改善的含有不可消化的低聚糖的发酵配方物 |
CN113924101A (zh) * | 2019-04-09 | 2022-01-11 | 因特因思克医药物公司 | 用于治疗疼痛的免疫调节寡糖 |
JP2021112165A (ja) * | 2020-01-20 | 2021-08-05 | 森永乳業株式会社 | 組成物並びに飲食品組成物、栄養組成物および調製乳 |
WO2022226311A1 (en) * | 2021-04-23 | 2022-10-27 | Abbott Laboratories | Nutritional compositions comprising human milk oligosaccharides and a designed lipid component for improving lung function |
WO2023118197A1 (en) * | 2021-12-20 | 2023-06-29 | Société des Produits Nestlé S.A. | Secretory iga-biotic complexes and uses thereof |
JP2024004736A (ja) * | 2022-06-29 | 2024-01-17 | 雪印メグミルク株式会社 | 気管支炎を予防するための栄養組成物 |
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WO1991016449A1 (en) | 1990-04-16 | 1991-10-31 | The Trustees Of The University Of Pennsylvania | Saccharide compositions, methods and apparatus for their synthesis |
US5545553A (en) | 1994-09-26 | 1996-08-13 | The Rockefeller University | Glycosyltransferases for biosynthesis of oligosaccharides, and genes encoding them |
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EP1062873A1 (en) * | 1999-12-13 | 2000-12-27 | N.V. Nutricia | Improved infant formula, protein hydrolysate for use in such an infant formula, and method for producing such a hydrolysate |
US6630452B2 (en) * | 2000-02-17 | 2003-10-07 | Wyeth | Nutritional formulation containing prebiotic substances |
ATE503007T1 (de) * | 2003-11-19 | 2011-04-15 | Nestec Sa | Isolierte bakteriophage und ihre verwendung in lebensmitteln oder zur sanierung der fabrik- umgebung |
MXPA06006392A (es) * | 2003-12-05 | 2007-03-15 | Childrens Hosp Medical Center | Composiciones de oligosacaridos y uso de estas en el tratamiento de infecciones. |
EP1629850B2 (en) * | 2004-08-24 | 2013-05-22 | N.V. Nutricia | Nutritional composition comprising indigestible transgalactooligosaccharides and digestible galactose saccharides |
RU2445361C2 (ru) * | 2006-06-13 | 2012-03-20 | Нестек С.А. | Профилактика и лечение воспаления среднего уха с помощью непатогенных штаммов бактерий |
EP2044851A1 (en) | 2007-09-26 | 2009-04-08 | Nestec S.A. | Prevention of allergy at weaning |
WO2009060073A1 (en) * | 2007-11-08 | 2009-05-14 | Nestec S.A. | Use of oligosaccharides containing n-acetyllactosamine for maturation of immune responses in neonates |
EP2060257A1 (en) * | 2007-11-08 | 2009-05-20 | Nestec S.A. | Prevention and treatment of secondary infections following viral infection |
EP2072052A1 (en) * | 2007-12-17 | 2009-06-24 | Nestec S.A. | Prevention of opportunistic infections in immune-compromised subjects |
EP2813230A1 (en) * | 2009-07-15 | 2014-12-17 | N.V. Nutricia | Fucosyllactose as breast milk identical non-digestible oligosaccharide for treating and/or preventing infections |
EP2454948A1 (en) * | 2010-11-23 | 2012-05-23 | Nestec S.A. | Oligosaccharide mixture and food product comprising this mixture, especially infant formula |
EP2465507A1 (en) * | 2010-11-23 | 2012-06-20 | Nestec S.A. | Oligosaccharide composition for treating skin diseases |
EP2465508A1 (en) | 2010-11-23 | 2012-06-20 | Nestec S.A. | Composition comprising hydrolysed proteins and oligosaccharides for treating skin diseases |
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2011
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RU2013128570A (ru) | 2014-12-27 |
CL2013001433A1 (es) | 2013-12-13 |
EP2465509A1 (en) | 2012-06-20 |
IL226348A0 (en) | 2013-07-31 |
SG190323A1 (en) | 2013-06-28 |
US9763465B2 (en) | 2017-09-19 |
EP2643006A1 (en) | 2013-10-02 |
MX343321B (es) | 2016-11-01 |
CA2818012A1 (en) | 2012-06-14 |
BR112013012598A2 (pt) | 2016-08-09 |
AU2011340882B2 (en) | 2016-10-20 |
US20130236424A1 (en) | 2013-09-12 |
RU2593321C2 (ru) | 2016-08-10 |
MX2013005727A (es) | 2013-07-03 |
CN103582485A (zh) | 2014-02-12 |
WO2012076323A1 (en) | 2012-06-14 |
AU2011340882A1 (en) | 2013-05-30 |
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