The National Science and Technology Council (NSTC) has long been dedicated to advancing basic and translational medical research, providing support to domestic biomedical researchers in various medical studies. It offers grants to exceptional teams pursuing academic excellence, exploring the causes of diseases and seeking innovative strategies for diagnosis and treatment in the field of medicine. These efforts aim to promote the health of the Taiwanese people and enhance the effectiveness of disease treatment. The achievement we are about to describe is the result of the continuous efforts of the Taiwan Gastrointestinal and Helicobacter pylori Clinical Trial Consortium, supported by the NSTC academic research projects. It was led by Professor Ming-Shiang Wu, the superintendent of the National Taiwan University Hospital, along with Professor Jyh-Ming Liou from the Department of Internal Medicine, Dr. Mei-Jyh Chen, Dr. Chieh-Chang Chen, Director Po-Yueh Chen from Chiayi Christian Hospital, and Director You-Ren Fang from the Yunlin Branch of the National Taiwan University Hospital. This multicenter research team utilized molecular methods to detect antibiotic-resistant gene and developed a novel treatment strategy which achieved a near 90% eradication success rate for patients who had previously failed multiple treatments for H. pylori infection. This is the first randomized trial which proved the efficacy of molecular testing guided therapy is not inferior to traditional susceptibility testing guided therapy for H. pylori infection. The research findings were published in the prestigious international journal "the Lancet Gastroenterology and Hepatology" in July of this year and was selected as the cover feature of the journal's current issue. This achievement has garnered significant international attention and has positioned Taiwan as a distinct and leading contributor in the field of medical research on the global stage. 

H. pylori is the most important causal factor of gastric cancer and peptic ulcer diseases. Eradication of H. pylori can reduce the risk of gastric cancer and the recurrence rate of peptic ulcers. However, in recent years, the antibiotic resistance rate of H. pylori is increasing globally. As a result, the eradication rate of empirical therapy has declined, necessitating precision treatment guided by antibiotic resistance testing. Traditional culture of H. pylori is challenging (with a success rate of only about 85-90%), time-consuming (2-3 weeks), and inconvenient for sample storage and transportation. Therefore, the clinical availability of H. pylori culture and sensitivity testing is relatively low. Recent research has found that the resistance of H. pylori to clarithromycin and levofloxacin is associated with point mutations in the 16S RNA and gyrA genes, respectively. Our previous studies have confirmed that these point mutations are correlated to treatment failure, and we have developed a method for directly detecting antibiotic resistance genes using gastric tissue specimens. This includes optimizing sample storage, DNA extraction, and PCR conditions, resulting in improved success rates (98-99%) and accuracy (>95%) of antibiotic resistance gene detection. 

From 2017 to 2021, through the multicenter platform of the Taiwan Gastrointestinal and Helicobacter pylori Clinical Trial Consortium, we conducted two clinical trials to compare the efficacy of first-line and third-line treatments guided by molecular testing for antibiotic resistance gene versus traditional bacterial culture and susceptibility testing. We recruited a total of 560 H. pylori-infected individuals who were naïve to eradication therapy and 320 individuals who had failed multiple treatments. Our results showed that in the first-line trial, the eradication rate of the molecular detection-guided treatment group was 86% (241/280), which was comparable to the eradication rate of the drug sensitivity testing-guided group (87%, 243/280). In the third-line trial, the eradication rate of the molecular detection-guided treatment group was 88% (141/160), which was also comparable to the eradication rate of the drug sensitivity testing-guided group (87%, 139/160). The results of these two clinical trials indicate that molecular detection-guided precision treatment of H. pylori is as effective as culture based susceptibility testing-guided treatment in both first-line and third-line therapy. The research findings support the use of molecular detection-guided treatment for precise guidance of H. pylori eradication. 

The research team collaborated with several renowned medical centers and hospitals in Taiwan, including National Taiwan University Hospital, Taipei Veterans General Hospital, Taipei Medical University Hospital, Mackay Memorial Hospital, National Taiwan University Hospital Hsinchu Branch, National Taiwan University Hospital Yunlin Branch, Chiayi Christian Hospital, Kaohsiung Medical University Hospital, and E-DA Hospital. With the support of the National Science Council and the Ministry of Health and Welfare, they jointly established the Taiwan Gastrointestinal and Helicobacter pylori Clinical Trial Consortium. The consortium aims to continuously develop the optimal treatment methods for gastrointestinal diseases, improve the health of the Taiwanese people, and promote the development of the biomedical industry. The innovative results of this clinical trial support the clinical application of molecular detection technology in precision treatment for H. pylori. The research team will continue to develop non-invasive specimen-based antibiotic resistance gene detection products and promote precision medicine for gastrointestinal diseases.

Media Contact
Yo-Chi Chang
Program Manager
Department of Life Sciences
National Science and Technology Council
TEL: +886-2-27377544
E-mail: yochang@nstc.gov.tw