A Double-blind, Parallel Designed, Randomized Controlled Trial to Investigate Effects of Conventional vs a2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants

The goal of this interventional study is to investigate effects of a2 Full Cream Milk on Breastmilk composition and subsequent Infant gut health, crying frequency and sleep patterns in Healthy Full-term Infants.
50 mothers and thier infants will be enrolled into 2 study sites, mother and her child as one subject will be randomized to 2 groups for assigned interventions, a2 Full Cream Milk and conventional Milk (Weidendorf). The study will continue for 14 days, and 3 site visits will be made duing the study period. All data specified in the protocol will be captured and recorded into CTMS for analysis.
Researchers will compare the two groups of participants to see if a2 Full Cream Milk has significantly better breastmilk composition and improve infant's gut health, crying frequency and sleep patterns.

开始日期2024-06-17

申办/合作机构

The a2 Milk Co. Ltd.

NCT06256094 / CompletedN/A

The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy, term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The participants were randomly assigned to one of the two study groups: the a2 infant formula group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The study duration was 56 days.

开始日期2023-07-14

申办/合作机构

The a2 Milk Co. Ltd.

NCT05741047 / CompletedN/A

Comparing the Effect of Powdered Skim Milk Containing A2 β-casein Only Versus Conventional Powdered Skim Milk Containing A1 and A2 β-caseins on Mild Cognitive Impairment in Older Adults: a Double-blind, Randomized, Controlled Trial

The aim of the study is to compare the effects of powdered skim milk containing A2 β-casein only versus conventional powdered skim milk containing A1 and A2 β-casein milk on cognition, inflammation, and dietary intake in adults aged 65-75 years.

开始日期2023-03-07

申办/合作机构

The a2 Milk Co. Ltd.

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2015-12-01·Nutrition journal3区 · 医学

Clinical evaluation of glutathione concentrations after consumption of milk containing different subtypes of β-casein: results from a randomized, cross-over clinical trial

3区 · 医学

ArticleOA

作者: Trivedi, Malav ; Clarke, Andrew ; Deth, Richard ; Ni, Jiayi

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov; identifier: NCT02406469.

2015-12-01·Nutrition journal3区 · 医学

Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows’ milk

3区 · 医学

ArticleOA

作者: Yelland, Gregory W ; Jianqin, Sun ; Lu, Xia ; Ni, Jiayi ; Clarke, Andrew J ; Leiming, Xu

BACKGROUND:

Cows' milk generally contains two types of β-casein, A1 and A2 types. Digestion of A1 type can yield the peptide β-casomorphin-7, which is implicated in adverse gastrointestinal effects of milk consumption, some of which resemble those in lactose intolerance. This study aimed to compare the effects of milk containing A1 β-casein with those of milk containing only A2 β-casein on inflammation, symptoms of post-dairy digestive discomfort (PD3), and cognitive processing in subjects with self-reported lactose intolerance.

METHODS:

Forty-five Han Chinese subjects participated in this double-blind, randomized, 2 × 2 crossover trial and consumed milk containing both β-casein types or milk containing only A2 β-casein. Each treatment period was 14 days with a 14-day washout period at baseline and between treatment periods. Outcomes included PD3, gastrointestinal function (measured by smart pill), Subtle Cognitive Impairment Test (SCIT), serum/fecal laboratory biomarkers, and adverse events.

RESULTS:

Compared with milk containing only A2 β-casein, the consumption of milk containing both β-casein types was associated with significantly greater PD3 symptoms; higher concentrations of inflammation-related biomarkers and β-casomorphin-7; longer gastrointestinal transit times and lower levels of short-chain fatty acids; and increased response time and error rate on the SCIT. Consumption of milk containing both β-casein types was associated with worsening of PD3 symptoms relative to baseline in lactose tolerant and lactose intolerant subjects. Consumption of milk containing only A2 β-casein did not aggravate PD3 symptoms relative to baseline (i.e., after washout of dairy products) in lactose tolerant and intolerant subjects.

CONCLUSIONS:

Consumption of milk containing A1 β-casein was associated with increased gastrointestinal inflammation, worsening of PD3 symptoms, delayed transit, and decreased cognitive processing speed and accuracy. Because elimination of A1 β-casein attenuated these effects, some symptoms of lactose intolerance may stem from inflammation it triggers, and can be avoided by consuming milk containing only the A2 type of beta casein.

TRIAL REGISTRATION:

ClinicalTrials.gov/NCT02406469.

2015-12-01·Nutrition journal

Erratum to: ‘Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows’ milk’

作者: Yelland, Gregory W ; Jianqin, Sun ; Lu, Xia ; Clarke, Andrew ; Ni, Jiayi ; Leiming, Xu

项与 The a2 Milk Co. Ltd. 相关的新闻（医药）

2024-03-09

·药明康德

让脑癌患者5年无癌的CAR-T疗法；挽救女儿生命，父亲助力开发的基因疗法进入临床… | CGT周报

▎药明康德内容团队编辑近期，全球细胞和基因疗法（CGT）领域迎来系列进展。由Mustang Bio和City of Hope联合开发的CAR-T疗法MB-101在治疗复发或难治性恶性胶质瘤的1期临床试验中表现出良好的安全性，1位获得完全缓解的胶质母细胞瘤患者已经无癌超过66个月。Iovance Biotherapeutics公司宣布，美国FDA许可该公司继续进行注册性临床试验IOV-LUN-202，评估其肿瘤浸润淋巴细胞（TIL）疗法LN-145治疗非小细胞肺癌（NSCLC）的效果。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF———✦研发进展✦———◇Mustang Bio和City of Hope宣布，双方联合开发的CAR-T细胞疗法MB-101治疗复发或难治性恶性胶质瘤，包括胶质母细胞瘤患者的1期临床数据已发表于Nature Medicine，这些数据展示了MB-101的良好安全性和临床活性，50%接受治疗的患者疾病稳定。MB-101是一款靶向IL-13受体α2（IL-13Rα2）抗原的CAR-T疗法。使用CAR-T疗法治疗脑瘤的一个主要挑战是CAR-T疗法难以穿过血脑屏障。City of Hope研究人员的策略是直接将CAR-T疗法注射到大脑肿瘤中（ICT），以及将CAR-T细胞注射到脑室中（ICV），让脑脊液携带它们到肿瘤病灶。试验结果显示：50%（29/58）接受治疗的患者在至少两个月内获得病情稳定或更好结果。这些患者都接受过大量治疗，属于难治类型。其中有两例部分缓解、一例完全缓解（CR），另一名患者通过同情用药渠道追加一次额外的CAR-T细胞治疗周期后也获得完全缓解。其中一名获得完全缓解的患者已经持续5年无癌。在使用ICT/ICV双重给药的优化治疗方案，并输注优化生产工艺制造的CAR-T疗法的患者亚群中，中位总生存期达到10.2个月，优于复发性GBM患者预期的6个月。◇Iovance Biotherapeutics公司宣布，美国FDA许可该公司继续进行关键性临床试验IOV-LUN-202，评估TIL疗法LN-145治疗晚期经治NSCLC患者的安全性和疗效。该公司的TIL疗法Amtagvi在2月16日获FDA加速批准上市，用于治疗晚期黑色素瘤患者。这是首款获批的TIL疗法，也是首款获批治疗实体瘤的T细胞疗法，是细胞疗法的又一里程碑。IOV-LUN-202试验的初步数据显示一次TIL治疗可提供潜在获益，包括比现有2线化疗可能更持久的缓解。在2023年11月的数据分析显示在确认获得缓解的患者中，71%的患者缓解持续时间超过6个月。◇A2 Biotherapeutics公司宣布，美国FDA已授予该公司开发的潜在“first-in-class”逻辑门控细胞疗法A2B530孤儿药资格，用于治疗肿瘤细胞表达CEA抗原，并且HLA-A*02表达缺失的结直肠癌患者。A2B530是基于该公司独有的技术平台开发的自体逻辑门控细胞疗法，它表达两种嵌合抗原受体（CAR），靶向CEA抗原的CAR会激活T细胞，而靶向HLA-A*02抗原的CAR会抑制T细胞活性。健康细胞由于表达HLA-A*02，不会被A2B530杀伤。而肿瘤细胞不表达HLA-A*02并且表达CEA抗原，将会激活A2B530。这一设计有望在杀伤肿瘤的同时保护健康细胞。目前该公司进行的1/2期临床试验正在进行患者招募。◇Cynata Therapeutics公司宣布，在研细胞疗法CYP-001治疗高风险急性移植物抗宿主病（aGvHD）的2期临床试验完成首例患者给药。CYP-001是该公司开发的一款由诱导多能干细胞分化而成的现货型间充质干细胞疗法。它们通过分泌生物活性分子可以起到免疫调节的作用。在治疗类固醇难治性aGvHD的1期临床试验中，CYP-001已经表现出可喜的安全性和疗效结果。美国FDA已授予其治疗aGvHD的孤儿药资格。◇Capricor Therapeutics公司公布了其主打细胞疗法CAP-1002治疗杜氏肌营养不良症（DMD）2期临床试验HOPE-2的24个月试验结果。CAP-1002是一种从健康供体心肌细胞中获取的基质细胞，具有免疫调节，抗炎症和抗纤维化的能力。试验结果显示，接受CAP-1002治疗的DMD患者24个月时与安慰剂组相比，疾病进展的速度减缓大约64%。CAP-1002同时为心脏功能提供具有临床意义的改善。◇诺华公司公布了治疗脊髓性肌萎缩症（SMA）的基因疗法Zolgensma的最新研究数据。这些数据来自比此前临床研究中入组儿童的年龄和体重更高的患者群体，其中包括曾经接受过其它药物治疗的患者。研究结果显示，几乎所有患者在接受一次性Zolgensma治疗后，达到在52周后维持或者改善运动功能里程碑。大部分曾经长期接受其它疗法治疗的患者停止使用此前接受的治疗。◇REGENXBIO公布了在研基因疗法RGX-202在4至11岁DMD患者中进行的1/2期AFFINITY DUCHENNE试验的额外中期安全性和有效性数据。试验数据显示，接受两种剂量水平的所有四例患者皆完成了在第三个月时的试验评估，分析显示其体内RGX-202微肌营养不良蛋白的表达皆有所增加，并且血清肌酐激酶（CK）水平较基线有所下降，显示该疗法具潜在临床疗效。首位接受剂量水平2治疗的12.1岁患者的数据显示，在三个月时其RGX-202微肌营养不良蛋白表达为标准对照的75.7%，且在十周时观察到患者的血清CK水平较基线降低了77%。◇Grace Science公司宣布，在研基因疗法GS-100的开放标签，1/2/3期临床试验完成首例患者给药。GS-100是一款使用重组AAV9载体，递送人类NGLY1基因的基因疗法，用于治疗NGLY1缺乏症。Grace Science公司的名字来自一名NGLY1缺乏症患者Grace。她的父亲Matt Wilsey先生与诺奖得主Carolyn Bertozzi博士联合创建了Grace Science公司，致力于开发治疗NGLY1缺乏症的基因疗法。相关阅读：当你的疾病无人知晓：致全球3亿名罕见病患者◇拜耳和BlueRock Therapeutics公司报告了双方联合开发的细胞疗法bemdaneprocel治疗帕金森病的1期临床试验最新结果。Bemdaneprocel是一款源于人类胚胎干细胞的多巴胺能神经元前体细胞疗法，它们通过手术被植入到帕金森病患者大脑中，目标是让这些细胞整合到患者大脑网络中，恢复运动和非运动功能。18个月的数据显示，bemdaneprocel表现出良好的耐受性，未发现重大安全性问题。在接受治疗12个月时停止免疫抑制后，移植细胞在18个月时仍然存活并定植于大脑中。探索性临床终点分析显示接受高剂量bemdaneprocel治疗的患者队列与低剂量组相比表现出更好的改善。2期临床试验计划在今年晚些时候开始注册患者。◇Precision BioSciences和iECURE公司宣布，已经获得英国监管机构的许可，在英国展开1/2期临床试验，评估体内基因编辑疗法ECUR-506治疗鸟氨酸转氨甲酰酶（OTC）缺乏症的效果。ECUR-506是一款体内基因编辑疗法，使用两个AAV载体递送不同载荷，一个载体递送ARCUS核酸酶在PCSK9基因位点上进行靶向基因编辑，另一个载体提供插入到这一位点的功能性OTC基因模板。这一疗法的目标是在PCSK9基因位点上通过基因编辑，持续表达OTC。大家都在看作为药明康德旗下专注于细胞和基因疗法的CTDMO，药明生基致力于加速和变革基因和细胞治疗及其他高端治疗的开发、测试、生产和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场，造福病患。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] City of Hope-developed Chimeric Antigen Receptor (CAR) T Cell Therapy Shows Clinical Activity in Patients With Aggressive Brain Tumors in a Phase 1 Trial. Retrieved March 7, 2024, from https://www.businesswire.com/news/home/20240307463963/en[2] Precision BioSciences Announces MHRA Approval for Partner iECURE to Expand Phase 1/2 Clinical Trial of ARCUS Gene Editing Program in OTC Deficiency. Retrieved March 8, 2024, from https://www.businesswire.com/news/home/20240306169732/en[3] Antion Biosciences announces latest data and validation of its technology platform through important milestone achievements. Retrieved March 8, 2024, from https://www.globenewswire.com/news-release/2024/03/06/2841232/0/en/Antion-Biosciences-announces-latest-data-and-validation-of-its-technology-platform-through-important-milestone-achievements.html[4] BlueRock Therapeutics phase I clinical trial for Parkinson’s disease continues to show positive trends at 18 months. Retrieved March 8, 2024, from https://www.globenewswire.com/news-release/2024/03/06/2841077/0/en/BlueRock-Therapeutics-phase-I-clinical-trial-for-Parkinson-s-disease-continues-to-show-positive-trends-at-18-months.html[5] GenSight Biologics Announces Update on Real-World Data from Early Access Programs of LUMEVOQ® Gene Therapy at NANOS 2024. Retrieved March 8, 2024, from https://www.businesswire.com/news/home/20240305810568/en[6] Grace Science, LLC Announces First Patient Treated in Phase 1/2/3 Trial of GS-100, an AAV9 Gene Therapy for NGLY1 Deficiency. Retrieved March 8, 2024, from https://www.businesswire.com/news/home/20240304132147/en[7] REGENXBIO ANNOUNCES NEW POSITIVE INITIAL EFFICACY DATA FROM AFFINITY DUCHENNE® TRIAL. Retrieved March 8, 2024, from https://www.prnewswire.com/news-releases/regenxbio-announces-new-positive-initial-efficacy-data-from-affinity-duchenne-trial-302079525.html[8] Novartis presents new data on safety and efficacy of Zolgensma, including maintained and improved motor milestones in older and heavier children with SMA. Retrieved March 8, 2024, from https://www.globenewswire.com/news-release/2024/03/04/2839221/0/en/Novartis-presents-new-data-on-safety-and-efficacy-of-Zolgensma-including-maintained-and-improved-motor-milestones-in-older-and-heavier-children-with-SMA.html[9] Capricor Therapeutics Presents at 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference. Retrieved March 8, 2024, from https://www.globenewswire.com/news-release/2024/03/06/2841425/0/en/Capricor-Therapeutics-Presents-at-2024-Muscular-Dystrophy-Association-MDA-Clinical-Scientific-Conference.html[10] First Patient Treated in Phase 2 GvHD Trial. Retrieved March 8, 2024, from https://www.prnewswire.com/news-releases/first-patient-treated-in-phase-2-gvhd-trial-302079209.html[11] Iovance Biotherapeutics Announces FDA has Lifted Clinical Hold on the IOV-LUN-202 Registrational Trial in Non-Small Cell Lung Cancer. Retrieved March 8, 2024, from https://www.globenewswire.com/news-release/2024/03/04/2839362/0/en/Iovance-Biotherapeutics-Announces-FDA-has-Lifted-Clinical-Hold-on-the-IOV-LUN-202-Registrational-Trial-in-Non-Small-Cell-Lung-Cancer.html免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

细胞疗法免疫疗法临床1期基因疗法上市批准

2023-04-05

·PRNewswire

a2 Milk® Adds Grassfed Whole & Reduced Fat Milk to Product Lineup

New Products Combine Two of the Fastest-Growing Milk Trends in the Natural Channel BOULDER, Colo., April 5, 2023 /PRNewswire/ -- The a2 Milk Company™ – the fastest growing premium milk brand in the U.S. – has expanded into grassfed milk in the U.S. with two new products that recently debuted at major natural food retailers including full nationwide distribution at Whole Foods and Sprouts. The new a2 Milk® Grassfed Whole Milk and a2 Milk® Grassfed 2% Reduced Fat Milk are Certified Regenerative by AGW, Non-GMO Project Verified, and Validus Certified for animal welfare and are among the first grassfed products in the A2 protein category. The new products pair two of the strongest performers in premium milk today. The grassfed segment grew nearly 25.8% in the natural channel over the 12 weeks ending January 29, 2023, while a2 Milk is the fastest growing brand of the top 10 premium milk brands for previous 52 weeks, according to the latest SPINS data ending January 29, 2023. a2 Milk also logged a 30% revenue increase in the U.S. during its last fiscal year. "As consumer interest in the a2 Milk brand continues to grow, adding a grassfed version is a natural progression that meets rising demand in this premium segment," said Blake Waltrip, CEO of The a2 Milk Company USA. "Combining the digestive benefits that some people experience with a2 Milk with the growing popularity of grassfed milk provides a compelling new dairy option for health-conscious consumers that will also help us continue to build our brand." Like all a2 Milk products, the company's new grassfed milk comes from cows that naturally produce only the A2 protein rather than the combination of A1 and A2 proteins contained in most dairy products. Published research suggests a2 Milk that naturally contains the A2 protein may help avoid stomach discomfort in some people. The a2 Milk Grassfed products come from cows that are on pasture every day, all year – with the nutrition and care they deserve. a2 Milk Grassfed Milk is Certified Regenerative by AGW. AGW Certified Regenerative farms are required to minimize disruption to the farm's ecosystem while using agricultural production to regenerate key environmental factors, such as soil health, water, biodiversity and air quality.1 Like other products in the a2 Milk range, a2 Milk Grassfed products are Verified Validus Animal Welfare Certified and Real Milk Certified. In addition to Whole Foods Market and Sprouts, it is available at other natural food retailers and on Amazon.com with Whole Foods delivery/pickup. About The a2 Milk Company The a2 Milk Company was founded in 2000 in New Zealand by Dr. Corran McLachlan after scientific research suggested that proteins in milk may affect some people differently. The company entered the U.S. market in 2015, works exclusively with U.S. farms that are Validus certified for animal welfare, and is now one of the fastest growing brands in the premium milk category in the U.S. with distribution in over 27,000 locations. a2 Milk comes from cows that naturally produce only the A2 protein. Published research suggests a2 Milk may help some people avoid stomach discomfort. For more information, visit a2milk.com. 1 SOURCE The a2 Milk Company

2022-11-02

·PRNewswire

FDA Infant Formula Update: November 2, 2022

SILVER SPRING, Md., Nov. 2, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency's increased flexibilities. Company (Product Origin): Danone (Ireland) The a2 Milk Company (New Zealand) Product(s): Danone: Aptamil Care Stage 1, 0-6 months, Infant Milk (800 grams (g) retail container) Aptamil Care Stage 2, 6-12 months, Follow On Milk (800 grams (g)) a2 Milk Company: a2 Platinum Infant Formula (0-6 months), 900g (a2MC Stage 1) a2 PlatinumFollow-on Formula (6-12 months), 900g (a2MC Stage 2) Type of Formula: General Availability: Both products will be sold at major U.S. retail outlets. The FDA is exercising enforcement discretion for the importation of the infant formula products listed above following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling and additional information about facility production and inspection history. Ongoing FDA Steps to Increase Availability of Safe, Nutritious Infant Formula The FDA has been leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition. The agency continues to dedicate all available resources to help ensure that safe and nutritious infant formula products remain available for use in the U.S. Important progress has been made toward improving the infant formula supply in the U.S. and paving the way for a more robust and diverse marketplace for the future. The FDA issued guidance in May 2022 that outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. This guidance also may provide flexibilities to those who manufacture infant formula products domestically and may be able to further increase the quantity of domestically-produced product for the U.S. market. Additionally, in September 2022, the FDA announced new guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure the U.S. continues diversifying its infant formula market, and make families less susceptible to shocks in the infant formula market. The agency continues to advise against making infant formulas at home or diluting formula. Parents and caregivers are encouraged to work with their child's health care provider for recommendations on changing feeding practices, if needed. The U.S. Department of Health and Human Services also has additional information available at HHS.gov/formula, including information to help families find infant formula. The FDA also monitors online marketplaces for fraudulent products and works with major online retailers to remove violative and harmful products offered for sale on their sites. Additionally, since many of these fraudulent products originate overseas, the agency targets and examines these products at ports of entry. The FDA also monitors and follows up on various external signals such as consumer complaints about potential counterfeit and fraudulent products. Additional Information: Infant Formula Information and Ongoing FDA Efforts to Increase Supply Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies HHS.gov/formula HHS.gov/news FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022) Powdered Infant Formula Recall: What to Know CDC Information on Cronobacter Infection and Infants Media Contact: FDA Office of Media Affairs, 301-796-4540 Consumer Inquiries: 888-723-3366 The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration

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