301 Hospital and Dongyuan Yikang Launch Clinical Trial of Oral Fecal Microbiota Capsules for Autism Spectrum Disorder in Children
On April 2, 2022, marking the 15th World Autism Awareness Day, the randomized, double-blind, placebo-controlled clinical trial on “Oral Gut Microbiota Capsule Transplantation for the Treatment of Childhood Autism” was officially launched. This initiative is a collaborative effort between Professor Yang Guang, Director of the Department of Pediatrics at the First Medical Center of the Chinese PLA General Hospital (hereinafter referred to as “301 Hospital”), and Dongyuan Yikang (Beijing) Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Dongyuan Yikang”). Both parties will jointly conduct in-depth exploration into the efficacy of gut microbiota capsule transplantation in improving symptoms among children with autism, as well as its underlying mechanisms of onset and progression, thereby seeking new therapeutic strategies and targets for the clinical management of autism.
The kickoff meeting invited Director Liu Liang from the First Medical Center of the Chinese PLA General Hospital, Minister Wu Jiajia from the Health Service Support Department, Professor Yang Ruifu from the Institute of Microbiology and Epidemiology at the Academy of Military Medical Sciences, Professor Cai Jun from Fuwai Hospital of the Chinese Academy of Medical Sciences, Professor Zhao Fangqing from the Beijing Institute of Life Sciences of the Chinese Academy of Sciences, and Mr. Lan Canhui, Dean of the Intestine Biotechnology Research Institute and founding initiator of the China Gut Conference. They respectively presented on the current state of social development in autism, innovations in medical technology, genetic and microbiota factors in the onset and progression of autism, and the clinical translational applications of fecal microbiota transplantation.
Since the launch of recruitment for this clinical study, over 900 families have registered, underscoring the urgent need for clinical treatments for autism spectrum disorder (ASD). As a novel and promising therapeutic approach for ASD, fecal microbiota transplantation (FMT) carries the hopes of countless clinicians and families of affected children.
Professor Yang Guang, Director of the Department of Pediatrics at the 301 Hospital, stated, “Autism spectrum disorder (ASD) has become a public health concern of global attention. Currently, there are no effective medications available to alleviate the core symptoms of autism. As a new target for human health, the gut microbiota not only plays roles in defending against infections, improving metabolism, and driving immune maturation, but also holds significant importance in nervous system development and signal transmission. Numerous studies have indicated that the developmental characteristics of gut microbiota in children with ASD significantly deviate from those in neurotypical children, and the degree of such deviation is significantly correlated with the severity of autistic symptoms. Basic and clinical experiments conducted by our center and other research institutions have also demonstrated that fecal microbiota transplantation can significantly improve both the core symptoms and gastrointestinal symptoms in children with autism.”
Dongyuan Yikang has been dedicated to advancing the health of the human microecology in China. By integrating global FMT donor screening standards and preparation methods from the United States, Europe, Australia, and China, the company has established drug-development-grade donor screening criteria and a quality control system. This approach ensures the safety of microbial capsules while maximizing bacterial viability and enhancing therapeutic efficacy. Furthermore, Dongyuan Yikang has built the largest microbiota resource center in North China, providing patients with access to a diverse range of microbiota resources.
Dr. Zhang, Chief Scientist at Dongyuan Yikang, stated, “It is a great honor to collaborate with Director Yang Guang from the 301 Hospital on research into the improvement of symptoms in children with autism and the underlying mechanisms of fecal microbiota transplantation (FMT). The 301 Hospital has extensive experience in the diagnosis and treatment of pediatric neurological disorders and enjoys a high reputation both domestically and internationally for its innovative therapies for autism. We hope that this collaboration will help deepen our understanding of the mechanisms linking the gut microbiota to autism, accelerate the development of microbiome-based therapeutics, and jointly establish new therapeutic approaches for autism.”
The Department of Pediatrics of the Chinese PLA General Hospital is a national key clinical specialty supported by the military, a military scientific and technological innovation team, the Institute of Pediatrics of the entire army, and a national training base for specialist physicians in neonatal medicine. Its affiliated Institute of Pediatrics hosts a National Engineering Laboratory, as well as key laboratories at both the all-army and Beijing municipal levels. The department’s medical specialties are characterized by “neonates, critical care, surgery, transplantation, genetic disorders, and developmental issues,” including the treatment of premature infants, pediatric hematopoietic stem cell transplantation and liver, kidney, and heart transplantation, diagnosis and treatment of functional genetic diseases, and the assurance of neuropsychiatric behavioral health along with the diagnosis and treatment of related disorders.
Dongyuan Yikang is a wholly-owned subsidiary of the Haodingrui Group, specializing in the medical and healthcare sectors focused on human gut microbiota. The company engages in gut microbiota testing, fecal microbiota transplantation (FMT), and the research and development of microbiome-based therapeutics. Dongyuan Yikang has established the largest microbial resource center and Good Manufacturing Practice (GMP) laboratory for microbiome products in North China. Adhering to the highest domestic and international standards, the company has implemented drug-grade donor screening criteria and quality control systems, thereby robustly ensuring the safety, efficacy, and traceability of its gut microbiota products. Currently, Dongyuan Yikang has established clinical collaborations with prestigious institutions such as Fuwai Hospital of the Chinese Academy of Medical Sciences, Beijing Chaoyang Hospital, Peking Union Medical College Hospital, Beijing Huilongguan Hospital, and Shaanxi Provincial People's Hospital.