MALAYSIAN-MADE PROBIOTIC BCMC® STRAINS PAVE WAY FOR MEDICAL BREAKTHROUGH IN MANAGING NON-COMMUNICABLE DISEASES (NCDS)马来西亚制造的益生菌 BCMC® 菌株为控制非传染性疾病(NCDs)
的医学突破铺平道路.
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PETALING JAYA, 7 MARCH 2023 - Malaysia’s medical community is reaching greater heights with newly unveiled medical breakthrough research of probiotic BCMC® strains produced by one of Malaysia’s leading pharmaceutical industry players - B-Crobes Laboratory Sdn. Bhd (B-Crobes) as a complementary therapy for Non-Communicable Diseases (NCDs). At their recent press conference, B-Crobes and Gut Research Group, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM) showcased newly found studies in the application of BCMC® strains.
The new study of BCMC® strains that were tested and clinically proven in improving and managing NCDs, specifically in Colorectal Cancer, Post-Gestational Diabetes (Pregnant Women with Diabetes), and Non-Alcoholic Fatty Liver Disease (NAFLD). For over two decades, B-Crobes has dedicated itself to the research, development, and manufacturing of specific strains of probiotics known as BCMC® strains consisting of Lactobacillus acidophilus BCMC® 12130, Lactobacillus casei subsp. BCMC® 12313, Lactobacillus lactis BCMC® 12451, Bifidobacterium longum BCMC® 02120, Bifidobacterium bifidum BCMC® 02290, and Bifidobacterium infantis BCMC® 02129, used to prevent and improve digestive health, metabolic health, immune system, and overall well-being.
More than 20 clinical studies have proved the BCMC® strains’ safety and efficacy - resulting in its products, namely ‘HEXBIO’ being used in intensive care units (ICU) of government hospitals and clinics across Malaysia. They are sold on the shelves of pharmaceutical stores internationally including the UAE, Bahrain, China, Oman, Singapore, Philippines, and many more.
The first study presented was “A Randomized Double-Blind Placebo-Controlled Trial on Post-Surgical Colorectal Cancer Patients” (1) - a study investigating the effects of BCMC® strains on post-surgical colorectal patients. The study was conducted through a blind trial with patients divided into two groups; one group receiving a placebo and the other receiving BCMC® strains at random, for 6 months of the recovery period.
It was found that the BCMC® strains led to a significant reduction in the levels of specific pro-inflammatory cytokines (harmful substances) that are known to cause poor outcomes and contribute to the development and recurrence of cancer in patients with colorectal cancer, thus, improving the recovery rate of post-surgical colorectal cancer.
The next study presented was “The Roles of Probiotics in the Gut Microbiots Composition Outcomes in Asymptomatic Post-Gestational Diabetes Women: A Randomized Controlled Trial” (2) which investigated the effects of BCMC® strains on glucose metabolism in postpartum women with a history of gestational diabetes mellitus (GDM). Participants were divided into two groups; one receiving a placebo and the other receiving BCMC® strains at random, for a total of 3 months.
The study also included meticulous and consistent testing of fasting glucose, insulin resistance, and inflammatory markers of the participants. It was found that the group supplied with BCMC® strains had significant improvements in their insulin resistance - which plays an important factor in managing post-gestational diabetes and decreasing the risk of developing Type 2 diabetes.
In the studies of NAFLD, two studies were presented - “The Effect of Probiotics (MCP® BCMC® Strains) on Hepatic Steatosis, Small Intestinal Mucosal Immune Function, and Intestinal Barrier in Patients with Non-Alcoholic Fatty Liver Disease” (3) and “The Effects of Probiotics on Small Intestinal Microbiota Composition, Inflammatory Cytokines and Intestinal Permeability in Patients with Non-Alcoholic Fatty Liver Disease.” (4)
Researchers investigated the effects of BCMC® strains on hepatic steatosis, fibrosis, and biochemical blood tests in patients with NAFLD. The study was done through a blind trial with two groups of patients, supplied with a placebo and BCMC® strains at random, for a total of 6 months.
Once the trial was concluded, it was found that the BCMC® strains managed to stabilize the mucosal immune function which protects NAFLD patients against intestinal permeability (preventing toxins from entering). In addition to this, the consumption of BCMC® strains also leads to a well-balanced microbiota composition, resulting in a healthy gut that deemed the BCMC® strains a complementary role in treating NAFLD and maintaining overall health.
YBrs. Puan Razida Hanim Abdul Razak, Director of Lifestyle & Sciences Section, Malaysia External Trade Development Corporation (MATRADE) shared, “This research does not only showcase the dedication and commitment of our industry leaders to provide efficient and clinically developed products for the health of the rakyat, but this also enhances the reliability and demand for Malaysian-made products internationally.”
Aligned with the Ministry of Health’s (MOH) National Strategic Plan 2016-2025 consisting of tackling issues in regard to NCDs, B-Crobes has signed a research agreement with the Faculty of Medicine, UKM, and the School of Medical & Life Sciences, Sunway University - announcing their academic and industrial collaboration for the clinical application of BCMC® strains and gut microbiomes in health. To kickstart this initiative, B-Crobes have provided an RM50,000 educational research grant to both parties as well as a full scholarship to two full-time Ph.D. students; one to the Faculty of Medicine, UKM and another one to the School of Medical and Life Sciences, Sunway University, to conduct probiotic-related research in Malaysia.
Puan Razida Hanim added, “I have no doubts that moving forward, the collaboration between B-CROBES, UNIVERSITI KEBANGSAAN MALAYSIA (UKM), and SUNWAY UNIVERSITY will nurture the medical and pharmaceutical industry in Malaysia to greater heights. This will also foster motivation for local players to dive deep into the unknown and uncover findings that will aid humanity at large as well as develop advanced innovations to benefit mankind and bring Malaysia forward as a reputable and reliable export country for medical products across the globe.”
Mr. Dean Lee, Executive Director of B-Crobes Group of Companies said, “This initiative is poised to provide the education and resources that will nourish students and up-and-coming researchers who will be future front liners in developing innovative offerings that showcase what Malaysia has to offer. In addition to that, conducting translational research is the way forward and it will also enhance the economy of Malaysia too. We believe this is an example of a quadruple-helix collaboration in clinical research and development between four major sectors namely industry, universities, government, and public. We hope that our objectives will also motivate our current and future industry players to strive for better medical discoveries that will contribute to our Malaysian society. Indeed, important research findings will be translated into clinical practice for the betterment of Malaysian society and beyond.”
Additionally, B-Crobes is also excited to share that due to the success of previous HEXBIO products used locally and internationally, they will be developing an all-new research facility in Batu Kawan, Penang set to open by the year 2025. The health of the rakyat is of paramount importance to B-Crobes, and these research breakthroughs only mark the beginning of their continuous journey in bringing Malaysia forward as a reputable and reliable source in the research and development of medical products across the globe.
References:
Colorectal Cancer study citation: Zaharuddin, L., Mokhtar, N.M., Muhammad Nawawi, K.N. et al. A randomized double-blind placebo-controlled trial of probiotics in post-surgical colorectal cancer. BMC Gastroenterol 19, 131 (2019). https://doi.org/10.1186/s12876-019-1047-4
Hasain Z, Raja Ali RA, Ahmad HF, Abdul Rauf UF, Oon SF, Mokhtar NM. The Roles of Probiotics in the Gut Microbiota Composition and Metabolic Outcomes in Asymptomatic Post-Gestational Diabetes Women: A Randomized Controlled Trial. Nutrients. 2022 Sep 19;14(18):3878. doi: 10.3390/nu14183878. PMID: 36145254; PMCID: PMC9504400. https://pubmed.ncbi.nlm.nih.gov/36145254/
Mohamad Nor MH, Ayob N, Mokhtar NM, Raja Ali RA, Tan GC, Wong Z, Shafiee NH, Wong YP, Mustangin M, Nawawi KNM. The Effect of Probiotics (MCP® BCMC® Strains) on Hepatic Steatosis, Small Intestinal Mucosal Immune Function, and Intestinal Barrier in Patients with Non-Alcoholic Fatty Liver Disease. Nutrients. 2021 Sep 14;13(9):3192. doi: 10.3390/nu13093192. PMID: 34579068; PMCID: PMC8468225. https://pubmed.ncbi.nlm.nih.gov/34579068/
Ayob, N.; Muhammad Nawawi, K.N.; Mohamad Nor, M.H.; Raja Ali, R.A.; Ahmad, H.F.; Oon, S.F.; Mohd Mokhtar, N. The Effects of Probiotics on Small Intestinal Microbiota Composition, Inflammatory Cytokines and Intestinal Permeability in Patients with Non-Alcoholic Fatty Liver Disease. Biomedicines 2023, 11, 640. https://doi.org/10.3390/biomedicines11020640
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(八打灵再也7日讯) – 随着马来西亚数一数二的制药业公司B-Crobes Laboratory Sdn. Bhd (B-Crobes) 所生产并作为非传染性疾病(NCDs)辅助治疗用途的益生菌BCMC® 菌株新近宣布取得突破性的医学研究成果，它也带动马来西亚的医学社会冲向更骄人的高度。在最近举办的一项新闻发布会上，B-Crobes连同马来西亚国民大学 (UKM)医学系的肠道研究小组发表了有关 BCMC® 菌株在应用方面最新发现的研究成果。
在新近的研究中，接受测试的BCMC® 菌株经临床证实能够改善及控制非传染性疾病，尤其是直结肠癌、后妊娠期糖尿病(患糖尿病的孕妇)以及非酒精性脂肪肝病(NAFLD)。过去二十多年来，B-Crobes一直积极献身于BCMC® 这种特殊益生菌菌株的研究、开发与制造的工作。它含有的菌株包括嗜酸乳杆菌 BCMC® 12130, 干酪乳杆菌 subsp. BCMC® 12313, 乳酸乳杆菌 BCMC® 12451, 长双歧杆菌 BCMC® 02120, 两歧双歧杆菌BCMC® 02290以及婴儿双歧杆菌 BCMC® 02129, 可用来预防及改善消化道健康、代谢健康、免疫系统及整体身心健康。
已经有20多项临床研究证明BCMC® 菌株的安全性与效能 – 因此全马各地政府医院的加护病房(ICU)和诊所也在使用它所研发的一种产品，称为‘HEXBIO’。此产品已在世界各地上架，包括阿联酋、巴林、中国、阿曼、新加坡、菲律宾等国家的西药房都买得到。
第一份提呈的研究是“针对手术后的直结肠癌病人进行的一项随机、双盲安慰剂对照试验” (1) – 此研究要查证的是 BCMC® 菌株对手术后直结肠癌病人产生的效应。研究是通过盲法试验进行，病人被分成两组；一组被施与安慰剂而另一组则随机被施与BCMC® 菌株，长达6个月的复原期。
结果发现，BCMC® 菌株显著降低了特定促炎性细胞因子(有害物质)的水平。据知这类因子会导致不良后果及促成直结肠癌病人身上癌症的发展与复发。正因如此，有关菌株才能改善手术后直结肠癌病人的复原率。
接着提呈的研究是“益生菌在无症状后妊娠期糖尿病女性的肠道微生物菌群之组成后果方面扮演的角色：一项随机对照控制的试验” (2)，它查证了BCMC® 菌株对拥有妊娠期糖尿病(GDM)病史的产后妇女之葡萄糖新陈代谢所产生的效应。参加者被分成两组：一组被施与安慰剂而另一组则随机被施与BCMC® 菌株，总共长达3个月。
该项研究也包含针对病人的空腹血糖、胰岛素阻抗及炎症指数进行精细和一致的测试。结果发现，被施与BCMC®菌株的那一组，他们的胰岛素阻抗有显著的改善 – 这在控制后妊娠期糖尿病及降低罹患第二型糖尿病风险方面扮演重大的角色。
至于有关NAFLD的研究，则提呈了两份研究 - “益生菌(MCP® BCMC® 菌株) 对非酒精性脂肪肝病患者的肝脂肪变性、小肠黏膜免疫功能及肠屏障所产生的效应”(3) 以及“益生菌对非酒精脂肪肝病患者的小肠微生物菌群组成、促炎性细胞因子及肠道通透性所产生的效应” (4)
研究人员验证了BCMC® 菌株对NAFLD患者的肝脂肪变性、线维症生化血液测试所产生的效应。研究是通过盲法试验进行，病人被分成两组；一组被施与安慰剂而另一组则随机被施与BCMC® 菌株，总共长达6个月。
当试验结束时，研究人员发现BCMC® 菌株能够稳定黏膜的免疫功能，借此保护NAFLD患者以免导致肠道通透性 (预防毒素进入)。此外，BCMC® 菌株的摄取也能促成达致良好平衡的微生物菌群组成，加强肠道健康，而研究人员也认同BCMC® 菌株可以辅助治疗NAFLD及维持整体健康。
马来西亚对外贸易发展机构(MATRADE)属下生活方式与科学部总监尊贵的Razida Hanim Abdul Razak女士说道： “这项研究不止显示我们的业界领导者积极献身投入于提供高效率兼临床研发的产品，以照顾广大国民的健康，它还能强化马来西亚制造的产品之可靠性，提高它们在世界各地的需求量。”
马来西亚卫生部(MOH)拟定的 2016-2025 年全国策略方案包括解决非传染性疾病(NCDs)的相关课题，为了配合此目标，B-Crobes 已经同马来西亚国民大学(UKM)医学系以及双威大学医药与生活科学系签署一份研究协议 – 并宣布他们将针对BCMC® 菌株的临床应用以及肠道微生物菌群的保健角色展开学术性与工商领域的合作。B-Crobes 为此倡议打响首炮，已率先拨出 RM50,000的教育研究补助金给双方以及一份全额奖学金给两名全日制博士生；一名来自马来西亚国民大学 (UKM)医学系，而另一名则来自双威大学医药与生活科学系，资助他俩在马来西亚展开跟益生菌有关的研究。
马来西亚对外贸易发展机构(MATRADE)属下生活方式与科学部总监尊贵的Razida Hanim Abdul Razak女士补充道：“我坚信在未来，B-CROBES、马来西亚国民大学 (UKM)以及双威大学之间的合作将继续培育人才，将马来西亚的医学与制药业带向另一个更高层次。这也将进一步激励本土业者更深入探索未知的领域，发掘更多对人类福祉普遍有益的真相，同时研发能够造福全人类的尖端革新成品，带领马来西亚迈步向前，成为全球备受尊崇及可信赖的医药产品出口国。”
B-Crobes集团有限公司执行董事 Dean Lee透露：“我们已准备就绪，透过这项倡议提供教育与资源栽培学生和后起之秀的研究人员，让他们充当未来的前线先锋，研发革新的成品以展现马来西亚胜人一筹的优势。此外，进行转化型研究是未来大势所趋，它同时也能强化马来西亚的经济。我们认为这个实例正好反映了工商界、大专院校、政府及公众人士这四大领域进行临床研究与开发的四重螺旋式合作。希望我们的目标也能激励当前和未来的业者奋力进行更完善的医学探索，以便对马来西亚社会作出贡献。重要的研究成果确实能够转化为临床实践，让马来西亚社会及更长远的将来更加尽善尽美。”
此外，B-Crobes也以兴奋的心情分享，由于此前的HEXBIO产品深受国内外用户欢迎，而且创下斐然售绩，他们将在槟州峇都加湾开设一座全新的制造设施，预料将在2025年启用。B-Crobes认为全民健康是至高无上的要务，而这些突破性的研究成果只预示着一个起点而已，他们将延续这段旅程，带动马来西亚成为全球备受尊崇兼可信赖的医药产品研发源头。
