JP2018502110A - 高脂肪ヒト乳製品を使用する気管支肺異形成症の予防及び治療方法 - Google Patents
高脂肪ヒト乳製品を使用する気管支肺異形成症の予防及び治療方法 Download PDFInfo
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Abstract
Description
本出願は、2014年12月30日出願の米国仮特許出願第62/098,151号の優先権を主張し、その内容は、参照によりその全体が本明細書に組み込まれる。
技術分野
本明細書に記載される高脂肪ヒト乳強化剤組成物、またはヒトクリーム強化剤組成物は、ヒト全乳から生産される。一実施形態において、ヒトクリーム組成物は、1mL当たり約2.0kcal〜約3.0kcal以上を含む。好ましい実施形態において、ヒトクリーム組成物は、約2.5kcal/mLを含む。ヒトクリーム組成物は、約18%〜約30%以上の脂肪(すなわち、脂質)を含み得ることが企図される。一実施形態において、ヒトクリーム組成物は、約25%の脂肪を含む。
本発明に従い、正常なタンパク質強化レベルを超えてタンパク質含有量を実質的に増加させることなく、高レベルのヒト脂肪、したがって総カロリーを送達するように製剤化される、標準化ヒト乳組成物も提供される。これらの標準化ヒト乳製剤は、貯留されたヒト乳から作製され、一般に30〜40Cal/ozを送達し、約1.5g/100kcal〜約3.0g/100kcalの範囲のタンパク質対エネルギー比を有する。より具体的には、PE比は、約1.8g/100kcal〜2.8g/100kcalの範囲である。ある特定の実施形態において、標準化ヒト乳組成物は、約70〜約100mg/mLの脂肪、及び約20〜約30mg/mLのタンパク質を送達する。これらの実施形態において、標準化ヒト乳組成物は、およそ80mg/mLの炭水化物も送達する。例示的な標準化ヒト乳組成物を表1に提供する。
表1:例示的な標準化ヒト乳組成物
本明細書で注目される乳組成物の1つの成分は、タンパク質である。体内で、タンパク質は、成長、酵素及びホルモンの合成、ならびに皮膚、尿、及び便から失われたタンパク質の置換に必要とされる。これらの代謝プロセスは、授乳中のタンパク質の総量及び特定アミノ酸の相対量両方の必要性を決定する。被検体のための授乳中のタンパク質の量及び種類の適切性は、成長、窒素吸収及び保持、血漿アミノ酸、ある特定の血液検体、ならびに代謝応答を測定することによって決定される。
本明細書に記載されるヒトクリーム組成物及び標準化高脂肪標準化ヒト乳組成物は、ヒト全乳から生産される。ヒト乳は、乳児の母親から、または1人以上のドナーから入手され得る。ある特定の実施形態において、ヒト乳は、ヒト乳の貯留物を提供するために貯留される。例えば、ヒト乳の貯留物は、2人以上(例えば、10人以上)のドナーからの乳を含む。別の例として、ヒト乳の貯留物は、1人のドナーからの2回以上の提供物を含む。
一般に、ヒト乳は、ドナーによって提供され、ドナーは、いかなる乳も加工される前にプレスクリーニングされ、承認される。様々な技法を使用して、好適なドナーを特定及び承認する。潜在的ドナーは、承認プロセスの一部として、自身の担当医及び子供の小児科医からリリースを得なければならない。これは、特に、ドナーが慢性疾患でないこと、及び子供が提供(複数可)の結果として罹患しないであろうことを保証するのを助ける。乳の回収及び分配を承認及び監視するための方法及びシステムは、例えば、参照によりその全体が本明細書に組み込まれる、米国特許出願第12/728,811号(US2010/0268658)に記載されている。ドナーは、提供に対して補償されてもされなくてもよい。
一旦ドナーが承認されると、乳がドナーにより自宅で搾乳され、母乳バンク施設で収集されない場合があるため、提供されたヒト乳に対してドナー識別マッチングを行ってもよい。特定の実施形態において、各ドナーの乳は、遺伝子マーカー、例えば、DNAマーカーに対してサンプリングされ、乳が真に承認されたドナーからのものであることを保証することができる。かかる被検体識別技法は、当該技術分野において既知である(例えば、参照によりその全体が本明細書に組み込まれる、国際出願第PCT/US2006/36827号を参照されたい)。乳は、検査結果を受領するまで保管され(例えば、−20℃以下)、隔離され得る。
次いで、乳を病原体について検査する。この乳は、例えば、HIV−1、HBV、及びHCV等のウイルスを識別するために、例えば、ポリメラーゼ連鎖反応(PCR)によって、遺伝学的にスクリーニングされ得る。様々な細菌種、真菌、及びカビについて培養を介してスクリーニングする微生物パネルを使用して、汚染物質を検出することもできる。例えば、微生物パネルは、好気性菌数、Bacillius cereus、Escherichia coli、Salmonella、Pseudomonas、大腸菌群、Staphylococcus aureus、酵母、及びカビについて検査することができる。具体的に、B.cereusは、低温殺菌を通じて除去することができない病原性細菌である。病原体のスクリーニングは、低温殺菌前及び低温殺菌後の両方に行われ得る。
一旦ヒト乳がスクリーニングされると、高脂肪製品、例えば、ヒトクリーム強化剤組成物または高脂肪標準化ヒト乳組成物を生産するために加工される。提供施設及び乳加工施設は、同じかまたは異なる施設であり得る。乳の加工は、大量のヒト乳、例えば、約75リットル/ロット〜約10,000リットル/ロットの出発物質(例えば、約2,500リットル/ロット、または約2,700リットル/ロット、または約3,000リットル/ロット、または約5,000リットル/ロット、または約7,000リットル/ロット、または約7,500リットル/ロット、または約10,000リットル/ロット)で実行され得る。
一旦クリーム部分が上澄み部分から分離されると、クリーム部分のカロリー含有量が測定される。好ましい一実施形態において、クリーム部分のカロリー含有量または含脂率は、所望のレベルを上回り、上澄み部分の超濾過からの透過液の量をクリーム部分に添加してもよく、それにより、所望のカロリー含有量を有する調合ヒトクリーム組成物を提供する。代替的に、別の好ましい実施形態において、製剤化ヒトクリーム組成物を提供するために、脱イオン水をクリーム部分に添加してもよい。例えば、ヒトクリーム組成物の所望のカロリー含有量は、1mL当たり約2.0kcal〜約3.0kcal以上である。好ましい実施形態において、所望のカロリー含有量は、約2.5kcal/mLである。別の実施例において、ヒトクリーム組成物の所望の含脂率は、約20%〜約30%以上の脂質である。ある特定の実施形態において、所望の含脂率は、約25%の脂質である。
透過液または脱イオン水をクリームに任意に添加した後、クリーム組成物を低温殺菌に供する。例えば、この組成物を、白金硬化シラスチック管を介して高温短時間(HTST)低温殺菌装置に接続された加工タンクに置くことができる。低温殺菌後、クリーム組成物を第2の加工タンクに収集し、冷却することができる。当該技術分野において既知の他の低温殺菌方法が使用され得る。例えば、静止低温殺菌において、タンク内のクリーム組成物を最低63℃に加熱し、最低30分間はその温度で保持する。クリーム組成物の上の空気は、クリーム組成物の温度より少なくとも3℃上に蒸気加熱される。一実施形態において、製品温度は、約66℃以上であり、製品の上の空気温度は、約69℃以上であり、製品は、約30分間以上低温殺菌される。別の実施形態において、HTST及び静止低温殺菌の両方が行われる。
本明細書に記載されるヒトクリーム組成物は、補助栄養として使用されてもよい。したがって、本明細書に記載されるヒトクリーム組成物は、経腸的または経口的に投与されてもよい(例えば、哺乳瓶授乳)。非経口栄養のためのヒト脂質の使用、経静脈栄養(例えば、総非経口栄養)の実施は、それを必要とする患者について、2007年12月10日出願のPCT出願第PCT/US07/86973号(WO2008/073888)に記載され、その内容全体が本明細書に組み込まれる。
ヒト乳クリーム強化剤製品
著しい容積量を添加することなく、母乳またはドナー乳に所望量のカロリーを添加することができる栄養補助を提供するために、経腸的に送達され得、それによりTPNに関連する負の効果を回避する、ヒトクリーム強化剤組成物を生産した。以前にスクリーニングされ、承認されたドナーからのヒト乳を一緒に混合して、ドナー乳の貯留物を生成した。清潔な室内環境において、ドナー乳の貯留物を、特定の病原体及びウシタンパク質についてさらに検査した。具体的に、PCR検査を使用して、乳中のHIV−1、HBV、及びHCVの存在についてスクリーニングした。好気性菌数、Bacillius cereus、Escherichia coli、Salmonella、Pseudomonas、大腸菌群、Staphylococcus aureus、酵母、及びカビについて検査する、微生物パネルも行った。
標準化高脂肪ヒト乳組成物
著しい容積量を添加することなく、高レベルのカロリーを送達することができる標準化調乳済み製剤を提供するために、経腸的に送達され得、それによりTPNに関連する負の効果を回避する、高脂肪ヒト乳ヒト組成物を生産する。以前にスクリーニングされ、承認されたドナーからのヒト乳を一緒に混合して、ドナー乳の貯留物を生成する。清潔な室内環境において、ドナー乳の貯留物を、特定の病原体及びウシタンパク質についてさらに検査する。具体的に、PCR検査を使用して、乳中のHIV−1、HBV、及びHCVの存在についてスクリーニングする。好気性菌数、Bacillius cereus、Escherichia coli、Salmonella、Pseudomonas、大腸菌群、Staphylococcus aureus、酵母、及びカビについて検査する、微生物パネルも行う。
極早産児に対するヒト乳クリーム製品の使用はより短い入院期間をもたらす
多施設治験において、調査場所の標準授乳プロトコルに従い、乳児に専用のヒト乳ダイエットを授乳した。このダイエットには、低温殺菌ドナーHM由来強化剤、Prolact+H2MF(Prolacta Bioscience,Industry,California)で強化した母乳または低温殺菌ドナーヒト乳が含まれていた。インフォームドコンセントが得られた後に、4つのブロックによって乳児を2つの群にランダム化し、そのサイズは盲検であった。研究群のマスキングは、論理的理由に起因して、研究場所のうちの1つにおいて得られただけであった。
表2.乳児の人口統計及び特性(平均±標準偏差)
表3.BPD下位群の人口統計
注記:この表におけるカテゴリーデータの全ての解析は、フィッシャーの直接検定またはその多項等式を使用した。
表4.研究乳児の臨床転帰
表5.BPDを有する乳児の臨床転帰
Claims (50)
- 気管支肺異形成症(BPD)を有するか、またはBPDを発症する危険性のある乳児における1つ以上の臨床転帰の改善方法であって、低温殺菌ヒト乳クリーム組成物で強化したヒト乳組成物を、前記乳児に投与することを含み、前記低温殺菌ヒト乳クリーム組成物が、約2.0kcal/mL〜約3.0kcal/mLを含む、方法。
- 前記低温殺菌ヒト乳クリーム組成物が、約25%の脂肪を含む、請求項1に記載の方法。
- 前記低温殺菌ヒト乳クリーム組成物が、透過液をさらに含む、請求項1に記載の方法。
- 前記透過液が、濃縮される、請求項3に記載の方法。
- 前記透過液が、希釈される、請求項3に記載の方法。
- 前記低温殺菌ヒト乳クリーム組成物が、脱イオン水をさらに含む、請求項1に記載の方法。
- 前記低温殺菌ヒト乳クリーム組成物が、約2.5kcal/mLを含む、請求項1に記載の方法。
- 前記低温殺菌ヒト乳クリーム組成物で強化したヒト乳組成物が、前記乳児の母である、請求項1に記載の方法。
- 前記低温殺菌ヒト乳クリーム組成物で強化したヒト乳組成物が、ドナー乳である、請求項1に記載の方法。
- 前記低温殺菌ヒト乳クリーム組成物で強化したヒト乳組成物が、標準化ヒト乳組成物である、請求項1に記載の方法。
- 前記低温殺菌ヒト乳クリーム組成物で強化したヒト乳組成物が、タンパク質含有強化剤でも強化される、請求項8、9、または10のいずれか1項に記載の方法。
- 前記タンパク質含有強化剤が、Prolact+(商標)である、請求項11に記載の方法。
- 前記低温殺菌ヒト乳クリーム組成物で強化したヒト乳組成物が、経腸的に投与される、請求項1に記載の方法。
- 前記改善された臨床転帰が、病院でのより短い入院期間である、請求項1に記載の方法。
- 前記入院期間が、約5日短い、請求項14に記載の方法。
- 前記入院期間が、約10日短い、請求項14に記載の方法。
- 前記入院期間が、約15日短い、請求項14に記載の方法。
- 前記入院期間が、約20日短い、請求項14に記載の方法。
- 前記改善された臨床転帰が、退院時におけるより早い月経後年齢である、請求項1に記載の方法。
- 前記退院時月経後年齢が、約1週間早い、請求項19に記載の方法。
- 前記退院時月経後年齢が、約3週間早い、請求項19に記載の方法。
- 前記退院時月経後年齢が、約6週間早い、請求項19に記載の方法。
- 低出生体重児における1つ以上の臨床転帰の改善方法であって、約1.5g/100kcal〜約3.0g/100kcalのタンパク質対エネルギー比を含む、標準化高脂肪ヒト乳組成物を、前記低出生体重児に投与することを含む、方法。
- 前記標準化高脂肪ヒト乳組成物が、約1.8g/100kcal〜約2.8g/100kcalのタンパク質対エネルギー比を含む、請求項23に記載の方法。
- 前記標準化高脂肪ヒト乳組成物が、経腸的に投与される、請求項23に記載の方法。
- 前記改善された臨床転帰が、病院でのより短い入院期間である、請求項23に記載の方法。
- 前記入院期間が、約5日短い、請求項26に記載の方法。
- 前記入院期間が、約10日短い、請求項26に記載の方法。
- 前記入院期間が、約15日短い、請求項26に記載の方法。
- 前記入院期間が、約20日短い、請求項26に記載の方法。
- 前記改善された臨床転帰が、退院時におけるより早い月経後年齢である、請求項23に記載の方法。
- 前記退院時月経後年齢が、約1週間早い、請求項31に記載の方法。
- 前記退院時月経後年齢が、約3週間早い、請求項31に記載の方法。
- 前記退院時月経後年齢が、約6週間早い、請求項31に記載の方法。
- 前記改善された臨床転帰が、体長の増加、体重の増加、及び/または頭囲の増加である、請求項23に記載の方法。
- 前記低出生体重児が、極低出生体重児である、請求項23に記載の方法。
- 前記低出生体重児が、BPDを有するか、またはBPDを発症する危険性がある、請求項23に記載の方法。
- 約1.5g/100kcal〜約3.0g/100kcalのエネルギー比を含む、標準化高脂肪ヒト乳組成物。
- 約1.8g/100kcalのタンパク質対エネルギー比を含む、請求項38に記載の標準化高脂肪ヒト乳組成物。
- 約38Cal/ozを含む、請求項39に記載の標準化高脂肪ヒト乳組成物。
- 約23mg/mLのヒト乳タンパク質及び約97mg/mLのヒト乳脂肪を含む、請求項39に記載の標準化高脂肪ヒト乳組成物。
- 約2.34g/100kcalのタンパク質対エネルギー比を含む、請求項38に記載の標準化高脂肪ヒト乳組成物。
- 約38Cal/ozを含む、請求項42に記載の標準化高脂肪ヒト乳組成物。
- 約30mg/mLのヒト乳タンパク質及び約94mg/mLのヒト乳脂肪を含む、請求項42に記載の標準化高脂肪ヒト乳組成物。
- 約2.16g/100kcalのタンパク質対エネルギー比を含む、請求項38に記載の標準化高脂肪ヒト乳組成物。
- 約32Cal/ozを含む、請求項45に記載の標準化高脂肪ヒト乳組成物。
- 約23mg/mLのヒト乳タンパク質及び約74mg/mLのヒト乳脂肪を含む、請求項45に記載の標準化高脂肪ヒト乳組成物。
- 約2.77g/100kcalのタンパク質対エネルギー比を含む、請求項38に記載の標準化高脂肪ヒト乳組成物。
- 約32Cal/ozを含む、請求項48に記載の標準化高脂肪ヒト乳組成物。
- 約30mg/mLのヒト乳タンパク質及び約71mg/mLのヒト乳脂肪を含む、請求項48に記載の標準化高脂肪ヒト乳組成物。
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EP (1) | EP3240429A4 (ja) |
JP (2) | JP7224760B2 (ja) |
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AU (1) | AU2015374053B2 (ja) |
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KR20190127583A (ko) * | 2018-05-04 | 2019-11-13 | 사회복지법인 삼성생명공익재단 | 기관지 폐 이형성증 (bpd) 예방 또는 치료용 물질 스크리닝 방법 |
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Publication number | Priority date | Publication date | Assignee | Title |
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CA2902990C (en) | 2013-03-13 | 2021-11-16 | Prolacta Bioscience, Inc. | High fat human milk products |
EP3397064A4 (en) | 2015-12-30 | 2019-10-30 | Prolacta Bioscience, Inc. | HUMAN MILK PRODUCTS USEFUL IN PRE- AND POST-OPERATIVE CARE |
WO2021146561A1 (en) * | 2020-01-17 | 2021-07-22 | Prolacta Bioscience, Inc. | Feeding protocol for optimal growth of preterm infants |
JP2022136404A (ja) | 2021-03-08 | 2022-09-21 | いすゞ自動車株式会社 | 冷却機構 |
AU2022245327A1 (en) * | 2021-03-26 | 2023-09-07 | Prolacta Bioscience, Inc. | Methods of treatment for failure to thrive |
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- 2015-12-30 JP JP2017534789A patent/JP7224760B2/ja active Active
- 2015-12-30 AU AU2015374053A patent/AU2015374053B2/en active Active
- 2015-12-30 CA CA2970533A patent/CA2970533C/en active Active
- 2015-12-30 CN CN201580076878.6A patent/CN107249342A/zh active Pending
- 2015-12-30 WO PCT/US2015/068050 patent/WO2016109659A1/en active Application Filing
- 2015-12-30 EP EP15876253.4A patent/EP3240429A4/en active Pending
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2018
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2020
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KR20190127583A (ko) * | 2018-05-04 | 2019-11-13 | 사회복지법인 삼성생명공익재단 | 기관지 폐 이형성증 (bpd) 예방 또는 치료용 물질 스크리닝 방법 |
KR102173673B1 (ko) | 2018-05-04 | 2020-11-03 | 사회복지법인 삼성생명공익재단 | 기관지 폐 이형성증 (bpd) 예방 또는 치료용 물질 스크리닝 방법 |
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AU2015374053A1 (en) | 2017-06-29 |
CA2970533A1 (en) | 2016-07-07 |
EP3240429A4 (en) | 2018-12-05 |
WO2016109659A1 (en) | 2016-07-07 |
AU2015374053B2 (en) | 2020-04-09 |
CN107249342A (zh) | 2017-10-13 |
JP7224760B2 (ja) | 2023-02-20 |
EP3240429A1 (en) | 2017-11-08 |
US20170367364A1 (en) | 2017-12-28 |
JP2021035993A (ja) | 2021-03-04 |
CA2970533C (en) | 2023-02-14 |
HK1245586A1 (zh) | 2018-08-31 |
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