Solving intestinal microbial industrialization: research on fecal transplantation is on the right track
September 23, 2016 Source: 21st Century Economic News
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Donating blood, donating organs, and donating waste to treat diseases. At present, the research on intestinal micro-organism related to feces has a global upsurge. Although the theoretical basis and clinical practice are extremely limited, the industry has long been eager to go to the forefront. "Guangzhou can donate money, earning 200 yuan each time." A paper “donation†volunteers’ call for announcements has once again triggered heated debates on manure transplants outside the industry. The publisher of the announcement is the First People's Hospital of Guangzhou (hereinafter referred to as “the First Hospital of the Cityâ€), and has always taken the Department of Gastroenterology as the dominant subject. Two years ago, the first digestive disease center in Guangzhou was established. This announcement is for the source of the project's research project “Study on the effectiveness and safety of fecal bacteria transplantation for ulcerative colitisâ€.
An interview with the 21st Century Business Herald was informed that the research project is part of a multi-center evidence-based study of fecal bacteria transplantation, and evidence-based research is expected to create a standard treatment plan. Up to now, the number of applicants has reached dozens, but only two have passed.
"At present, the world has linked the intestinal flora to health and disease, providing a better medical environment. The most difficult to treat in the digestive department is inflammatory bowel disease. Many hospitals around the world are trying to treat fecal bacteria. However, there is a lack of further argumentation research. After the completion of this project, we want to build a manure library in Guangdong or South China.†Nie Yuqiang, deputy dean of the First Hospital and director of the Department of Gastroenterology, told the 21st Century Business Herald.
Manure transplantation is not new, but it has only gradually become known to the public in recent years. The clinical research and application specifications of fecal bacteria transplantation dose and route, preparation of fecal bacteria have not been introduced.
At the same time, the application of intestinal microbiology at home and abroad has attracted a large number of entrepreneurial teams, companies and capitals. The scope of research also extends from the initial association with digestive health to obesity, diabetes, the immune system, cancer and even the health of future generations.
Solving intestinal microbial industrialization: research on fecal transplantation is on the right track
Manure transplantation research is on the right track
“At first, I felt that this technology is very brutal and lacks standardized operations. For example, how to remove other substances in the feces, how to eliminate the pathogenic bacteria, how to retain the required flora, the composition of the fecal bacteria and the intestinal bacteria are not exactly the same, whether it can be started after transplantation. To the role of intestinal bacteria. But the practical effect is still relatively good." Chen Long, an associate professor of Jinan University who studies intestinal microbes in the doctoral stage.
According to the official website of the Chinese Manure Library, the 2013 fecal transplant was included in the American Medical Guide and was selected as the “World's Top Ten Medical Breakthroughs†in the 2013 American Time Magazine. Up to now, there have been about 15,000 cases of fecal bacteria transplant treatment in the world, and there are two non-profit fecal bacteria banks in the United States.
It is recognized in the industry that the best effect of fecal bacteria treatment is pseudomembranous colitis, which is a disease caused by C. difficile.
Nie Yuqiang said that the incidence of pseudomembranous colitis is very high and difficult to treat. Most patients suffer from bacterial flora, diarrhea and even ulceration due to taking antibiotics. And the more severely ill patients, the more likely they are suffering from pseudomembranous colitis, and they cannot stop using antibiotics.
"The mechanism of this disease is very clear, and the treatment methods are being studied all over the world. The therapeutic effect of fecal bacteria is also controversial. Some are effective in extracting and transplanting multiple fecal bacteria, and some are single effective. However, there are precedents for successful treatment of fecal bacteria, but there is no control study. Foreign countries have done random double-blind comparisons and animal experiments, and the progress is faster than ours." Nie Yuqiang said.
To this end, the First Hospital of Guangzhou joined the evidence-based research program led by Xijing Hospital, trying to study the standardized treatment plan through multi-center demonstration. The research project of the First Hospital of the City is expected to take two years and the funding is 4 million. The projects of the remaining member hospitals are also in their infancy.
However, qualified manure sources are not easy to find.
The announcement of volunteers from the First Hospital of the city showed that in addition to medical indicators such as “no history of infectious diseases, diabetes and malignant tumors†and “no antibiotics used in the past 3 monthsâ€, the age and education of volunteers were also The area has made a request.
Nie Yuqiang told the 21st Century Economic Reporter that the current hospital has screened the fecal source according to the clinical drug research standard, and the volunteers should further screen after registration. Screening includes not only routine physical examinations, but also syphilis screening, parasite testing, and cytomegalovirus testing. Most of these tests are performed in the hospital's laboratory, and some are in collaboration with out-of-hospital testing organizations. The cost of screening a volunteer is 5,000 yuan.
After obtaining the volunteers, the doctor will extract the bacteria from the feces by pulping, centrifugation, suspension and other processes under aseptic conditions, and finally inject into the patient's digestive tract. The artificial separation system for fecal bacteria used in the preparation process is about 400,000.
Nie Yuqiang said frankly: "The United States has developed a special guide for this project, including the specification of manure treatment, but China has not. The dose of transplantation is the focus of current research, and the dosage, time and frequency of transplantation should be grasped according to different individuals."
In addition to recruiting fecal donors, the City First Hospital is also recruiting subjects who are treated with a fecal transplant. The current research program is "fecal bacteria transplantation + basic drug treatment". According to the individual reaction, the fecal bacteria transplantation needs to be carried out three or four times, usually once a week. The drug treatment time is longer, the observation period is three months, and there is a tracking period of six months to one year after the treatment is successful. The subject's treatment costs are free.
Market products are constantly emerging
Advances in sequencing technology and price diving have boosted the popularity of intestinal microbes.
Li Ting, a senior researcher at Gao Tejia Investment Research Department, pointed out that in recent years, DNA sequencing technology has developed rapidly, extending the gut microbiology, and the treatment risk is gradually controllable, so the fecal therapy suddenly develops rapidly.
As a relatively mature therapy in the field of intestinal microbes, even if the research is successfully completed, it still faces promotion problems. "There is still a stage of clinical research, and there is no perfect clinical standard. Because there are still some risks, and the fecal transplant is not easily accepted by the public, it is only suitable for some patients." Li Ting said.
His concerns stem from the complexity of the gut microbes.
More than 99% of the microorganisms in the human intestine are bacteria, and the number of survivors is about 100 trillion, including 500 to 1000 different species, which can be roughly divided into three categories: beneficial bacteria, harmful bacteria and neutral bacteria.
Nie Yuqiang told the 21st Century Business Herald: "Bacteria and the human body are symbiotic, and can produce many useful substances. Humans also have immune functions against bacteria and kill harmful bacteria. But there are synergistic and competitive relationships between bacteria, which can kill each other or Coexistence and coexistence. To understand so many relationships, the workload and technical requirements are very difficult. The current transplant is just to adjust and restore the status of the flora."
Even if it is a flora or a strain transplant, it faces a standardization problem.
Taking fecal transplantation as an example, clinically proven cases are also difficult to maintain uniformity in the quality control of fecal sources, because different people have different fecal sources, and people's eating habits will change the fecal source. In addition, what flora is healthy, there is no standard of judgment yet.
Chen Long believes: "If you carry out the mixed culture of a variety of bacteria, and then transplant the bacteria, you can advance the research and treatment under the premise of this standardization."
Li Ting pointed out: "The variety of intestinal microbes is complex, the growth environment is complex, artificial culture is difficult to simulate its environment, and some microorganisms are difficult to survive, or can not adapt to death from the artificial environment to the real intestinal environment, resulting in failure to function. â€
However, domestic intestinal microbial projects and products have emerged in an endless stream, mainly for improving obesity and chronic disease management. This area is the focus of the gene giant's layout.
Among them, Boao and this year launched the round-dream spectrum of intestinal flora for comprehensive analysis of intestinal micro-ecology (biota diversity, probiotics, pathogenic bacteria, etc.), assessment of diabetes, obesity and intestinal tract The risk of disease such as stimuli and immunity. The JiuyetangTM probiotic solid beverage has also been developed for conditioning to improve the imbalance of different intestinal flora.
The BGI gene also took eight years to study intestinal microbes. The 21st Century Business Herald reporter saw in the e-commerce platform of Huada Gene that the enteric nutrition foods currently have female probiotic solid drinks, probiotic powder, inulin probiotic tablets, and composite probiotic tablets. The price is 78 yuan to 399. The functions include “balanced intestinal flora, improve intestinal environment†and “effectively proliferate probiotics in the intestinal tractâ€.
Many startups are also racing to start on this track. For example, a week ago, using gene sequencing and big data means to analyze and interpret the hcode of the bacterial characteristics of various parts of the user, and complete the financing of 10 million Pre-A rounds; the intestinal microbiological testing company quantified the health and completed the 20 million RMB Pre-A round in October last year. Financing; Kayudi launched a gut microbiota test product in early September.
Chen Long said that the industrialization of intestinal microbes has two major challenges: First, the lack of intervention tools, even if the difference in flora is found, there is no tool to accurately control a certain type of bacteria; second, the causal relationship is still controversial. Some people think that the difference in intestinal flora is related to human health, but it is not a causal relationship, because the host's human genotype determines which intestinal bacteria can symbiosis.
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