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Human Practices

Background

We are a group of high school students from both domestic and international schools, brought together by our shared passion for synthetic biology. Initially, we were quite unsure about the direction of our project and the target audience we wanted to serve, which led to multiple group discussions. During one of our meetings, one of our team members, Zhong, suddenly experienced severe abdominal pain. After rushing him to the hospital and conducting tests, we learned that Zhong was diagnosed with acute Inflammatory Bowel Disease (IBD). While visiting him in the hospital, we had a brief conversation with his attending doctor. The doctor informed us that the mechanism of IBD is quite complex, but early intervention can lead to better treatment outcomes. Inspired by the doctor’s advice, we decided to develop a treatment.

Project design phase
Online Survey

We conducted an online survey to gauge the public's awareness of IBD and explore the main reasons why people are hesitant to go to the hospital for examinations.


Data shows that most people lack sufficient understanding of IBD, with only a small portion possessing some basic knowledge, though their understanding is limited. This finding made us realize that providing detailed usage instructions during product development is essential. Additionally, we need to enhance public awareness of IBD through health education, helping them better understand the early symptoms and preventive measures of the disease. This will ensure that our product can truly be effective and meet users' health needs.


Data shows that due to the public's limited understanding of IBD, many people are unfamiliar with existing IBD testing methods. Even among those who have some knowledge of the condition, about 70% believe that the current testing methods are not convenient enough. We need to provide a simpler and more accessible testing solution.


Among those who are familiar with IBD testing methods, the most concerning issue is the discomfort experienced during the testing process.

Summary

Many people lack sufficient understanding of the early symptoms of IBD and often delay seeking medical attention due to concerns about the discomfort that may arise during the examination process. This delay not only prevents timely diagnosis and treatment but can also lead to worsening symptoms and a more severe condition. Developing more comfortable, non-invasive testing methods is key to addressing this issue and has become an important consideration in our product design.

Stakeholders
Inflammatory Bowel Disease (IBD) patients

In our conversation, a patient shared that when she initially experienced abdominal pain, she didn't take it seriously, thinking it was just a minor issue, possibly due to catching a cold or poor diet. As the discomfort persisted, she eventually decided to get checked. After researching online, she learned that a colonoscopy was required, which caused psychological resistance, as she believed the procedure would be too painful and thus was reluctant to go to the hospital. This attitude led to the worsening of her condition. Her experience reflects that many people often don't take the symptoms of Inflammatory Bowel Disease (IBD) seriously, and the inconvenience and psychological stress of traditional testing methods make patients more likely to delay seeking medical help, exacerbating their health problems.

Families of IBD Patients

We interviewed the families of Inflammatory Bowel Disease (IBD) patients to gain insight into the challenges of early diagnosis and routine monitoring. Many patients avoid necessary health check-ups, not because of busy schedules, but due to the fear of undergoing invasive procedures like colonoscopies. This fear leads them to delay or forgo regular screenings, making it difficult to manage their condition effectively. Despite encouragement from their families, this hesitation results in missed opportunities for early diagnosis and proper health monitoring.


Dr. Yang from the Gastroenterology and Proctology Hospital

We consulted Dr. Yang online and learned that a colonoscopy, performed through the anus, costs between 800 and 1,000 yuan. Even with subsidies for certain groups, patients still need to pay 199 yuan. Beyond the high cost, the process also requires patients to visit a hospital for approximately half a day, making it inconvenient for self-diagnosis or for diagnosis in smaller clinics. This further limits access to timely and affordable medical care, contributing to delays in addressing symptoms of inflammatory bowel disease.


Summary

The progression of intestinal inflammation into a chronic disease is mainly due to the lack of early diagnosis. The current diagnostic methods are invasive, making many people psychologically resistant. Additionally, there is a lack of awareness about the severity of intestinal inflammation, high costs, and the need for specialized equipment, which limits regular monitoring. These factors combined make it difficult for current methods to be used for routine check-ups or early diagnosis. As a result, many patients only discover the disease after it has developed into a chronic condition, making treatment more challenging.


To address these issues, our goal is to design:1、a non-invasive, 2、home-use, 3、affordable, and 4、easy-to-operate IBD testing method that helps users easily monitor their intestinal health, promoting early detection and intervention.


Project experimental phase

After reviewing extensive literature, we designed the first version of the IBD detection system. Escherichia coli can detect tetrathionate in the intestines and indicate the presence of inflammation through a color change.

Biomedical Expert

After discussing our project with biomedical expert, she pointed out that tetrathionate is quickly metabolized by microorganisms in the intestines, leading to unstable signals, making it difficult to continuously and effectively detect intestinal inflammation. Based on this feedback, the experts recommended developing a thiosulfate sensing system as an alternative to improve the reliability and consistency of detection. Following this suggestion, we adjusted our project direction in subsequent designs, shifting to a thiosulfate sensing system to ensure more stable and accurate inflammation detection results in the intestinal environment. This improvement not only enhanced the system's sensitivity but also laid a foundation for more effective detection.


Interview with Pharmacists

Through our interview with pharmacists, we learned that there are many issues with current medications for treating intestinal inflammation. For example, the overuse of antibiotics can lead to resistance, and long-term use of steroids may cause damage to other organs in the body. Additionally, most existing treatments only alleviate symptoms and do not offer long-term cures. These issues made us realize that the market needs a safer and more effective solution.


Doctors from the Proctology Department of Southern Hospital

We had a discussion with proctology doctors, who highlighted that during flare-ups of Inflammatory Bowel Disease (IBD), the intestinal mucosal barrier is compromised. The key to treatment is quickly restoring the integrity of the intestinal epithelium. While Epidermal Growth Factor (EGF) is highly effective for this, it cannot be administered orally. Based on the doctors’ suggestions, we optimized our experimental design to integrate EGF into E. coli, enabling it to produce EGF directly in the gut. This would allow for in situ treatment, combining both detection and rapid mucosal repair, offering a more efficient approach for IBD therapy.



Biomedical Expert

During our discussion with biomedical experts, they suggested that we could enhance the therapeutic effect by increasing the secretion of Epidermal Growth Factor (EGF). After further discussion, we decided to adopt the ⍺-Hemolysin A (Hemolysin A) secretion system. This system is composed of the proteins hlyB and hlyD, which can regulate the efficient secretion of EGF through the Hly signal peptide. This choice not only improved the secretion efficiency of EGF but also optimized the overall stability of the system, providing strong support for our integrated design of detection and treatment. By introducing this secretion mechanism, our solution has seen significant improvements in both functionality and effectiveness.


Synthetic Biology Forum

Our team members attended the Synthetic Biology Forum, during which several professors repeatedly emphasized the importance of biosafety in synthetic biology. This made us deeply realize that ensuring the biosafety of our project is crucial. Therefore, we decided to include a dedicated biosafety section in our project to enhance the management of potential risks and ensure that our design and applications comply with relevant biosafety standards.


Biomedical Expert

We collaborated with a researcher to discuss the design of a suicide system. Ultimately, we developed a suicide mechanism based on the MazE/F toxin-antitoxin system. This system allows engineered bacteria to survive in the intestines for a short period and then automatically die after completing their therapeutic task, thereby avoiding the biosafety risks associated with long-term survival. Additionally, the system is controllable, with bacterial survival regulated by external conditions, which facilitates testing and cultivation in the laboratory. Specifically, the expression of MazE is regulated by the rhamnose-induced promoter (pRHa). When sufficient rhamnose is ingested, MazE can effectively neutralize the MazF toxin, preventing bacterial death. This mechanism ensures the safety of the engineered bacteria.


Project implementation stage

We understand that fully developing and realizing the project is a relatively long journey. Therefore, while promoting the long-term research and development of the project, we have also taken some practical measures to help industrial patients in the current phase. Moreover, we are actively exploring future research directions for the project, aiming to optimize the technical solutions to bring more effective treatments to patients in the near future. Through these efforts, we hope to create tangible value for the industry and patients while gradually advancing the project.


Lawyer

We interviewed a lawyer from Guangdong Songjie Law Firm to gain a detailed understanding of the safety regulations that must be followed during the project development process. These include the "Regulations on the Safety Management of Agricultural Genetically Modified Organisms," the "Environmental Protection Law of the People's Republic of China," the "Biosafety Law of the People's Republic of China," and the "Consumer Rights Protection Law of the People's Republic of China," among others. These laws and regulations provide important guidance for ensuring the compliance and safety of our project.


Biological Expert

We had a discussion with biomedical experts about our project, and the experts gave it positive feedback, recognizing its potential for future applications. At the same time, the experts emphasized the importance of prioritizing biosafety throughout the project's development, especially considering that our product is intended for use in the human body. Before the product is officially launched, it is crucial to ensure that it complies with relevant biosafety standards and regulations, ensuring that it poses no potential risk to humans or the environment in practical use. This feedback has provided us with valuable guidance for the project's subsequent development and strengthened our awareness of biosafety responsibilities.


Public Lecture on World Inflammatory Bowel Disease Day

We attended a public lecture on World Inflammatory Bowel Disease (IBD) Day, where we gained in-depth knowledge about the pathogenesis and treatment strategies for IBD. During the lecture, we not only learned about the current common treatment methods for IBD but also gained a more comprehensive understanding of the safety of existing treatment drugs. This lecture helped us further clarify the direction for future research and development of our project.


Understand the freeze-drying process

We visited Sun Yat-sen University to gain in-depth knowledge of the production process of lyophilized powder. This learning experience provided crucial technical support for the development of our product, helping us further optimize the production process to ensure its stability and effectiveness. This knowledge foundation has laid a solid groundwork for our subsequent product development.


Product User Manual

Although our product has not yet been officially launched, we have already prepared a product user manual in advance. This will help future users understand how to use the product properly.



Alipay Charity Donation

In response to the high cost of testing and treatment for intestinal diseases, particularly in underdeveloped regions, we identified a charitable organization on the Alipay platform that helps financially struggling families with medical expenses. To support this cause, all nine members of our team launched a donation campaign aimed specifically at aiding patients with intestinal diseases in disadvantaged areas. Through this effort, we hope to provide much-needed relief to families facing significant medical burdens and help them navigate through difficult times.


Guangzhou Synthetic Biology Industry-Academia-Research Exchange Conference

We participated in the Guangzhou Synthetic Biology Industry-Academia-Research Exchange Conference, where we gained comprehensive insights into the entire process of translating synthetic biology research into real-world industrial applications. The conference featured experts from various fields who discussed key stages such as research commercialization, regulatory hurdles, and the development of market-ready biotechnological products. By attending this event, we were able to understand the collaborative dynamics between academia and industry, as well as the challenges and opportunities involved in bringing innovative synthetic biology solutions to market.


Pharmaceutical Practice Training Program

We attended a pharmaceutical practice training course that provided us with an in-depth understanding of the various stages involved in drug development and production. The training covered key processes such as drug discovery, formulation, testing, and manufacturing. By engaging in this course, we were able to grasp the complexities of pharmaceutical production, including regulatory compliance and quality control measures. This experience has greatly enhanced our professional knowledge, laying a strong foundation for the successful development and implementation of our project in the realm of synthetic biology and drug application.


Future Outlook

In the future, we will continue to conduct market research, gain deeper insights into user needs, and continuously optimize the project design. We strive to provide our target users with a non-invasive, home-use, affordable, and easy-to-use testing method for Inflammatory Bowel Disease (IBD). This solution will help users easily monitor their gut health, promote early detection and timely intervention, and effectively reduce the risk of IBD worsening. Our goal is to enable users to manage their health more conveniently while improving overall quality of life.