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  • IDDF2024-ABS-0375 Multi-centre, open-label, randomized controlled trial of amoxicillin dosage in vonoprazan dual helicobacter pylori therapy: effects on cure rate, gut microbiota and antibiotic resistome

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Young Investigator Award
Clinical Gastroenterology
IDDF2024-ABS-0375 Multi-centre, open-label, randomized controlled trial of amoxicillin dosage in vonoprazan dual helicobacter pylori therapy: effects on cure rate, gut microbiota and antibiotic resistome
  1. Yi Hu1,
  2. Zhen-Yu Zhang2,
  3. Fen Wang3,
  4. Kun Zhuang4,
  5. Xin Xu1,
  6. Dong-Sheng Liu1,
  7. Hui-Zhen Fan5,
  8. Li Yang6,
  9. Kui Jiang7,
  10. De-Kui Zhang8,
  11. Long Xu9,
  12. Jian-Hua Tang10,
  13. Xue-Mei Liu11,
  14. Cong He1,
  15. Xu Shu1,
  16. Yong Xie1,
  17. James YW Lau12,
  18. Yin Zhu1,
  19. Yi-Qi Du13,
  20. David Y Graham14,
  21. Nong-Hua Lu1
  1. 1Department of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi Province, China
  2. 2Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China
  3. 3Department of Gastroenterology, Hunan Key Laboratory of Non-Resolving Inflammation and Cancer, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China
  4. 4Department of Gastroenterology, Xi an Central Hospital, College of Medicine, Xi an Jiaotong University, Xi an, China
  5. 5Department of Gastroenterology, The People Hospital of Yichun City, Jiangxi, China
  6. 6Department of Gastroenterology, The Third People Hospital of Jingdezhen, Jingdezhen, Jiangxi Province, China
  7. 7Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin Institute of Digestive Diseases, Tianjin Key Laboratory of Digestive Diseases, China
  8. 8Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, Gansu Province, China
  9. 9Department of Gastroenterology and Hepatology, Shenzhen University General Hospital, Shenzhen, China
  10. 10Department of Gastroenterology, Ganzhou People Hospital, Ganzhou, Jiangxi, China
  11. 11Department of Gastroenterology, Digestive Disease Hospital, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou Province, China
  12. 12Department of Surgery at the Sir YK Pao Centre for Cancer, The Chinese University of Hong Kong, Hong Kong, China
  13. 13Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China
  14. 14Department of Medicine, Michael E. DeBakey VA Medical Center, and Baylor College of Medicine, Houston, USA

Abstract

Background To investigate the amoxicillin dosage required to achieve high cure rates, we compared 2 and 3 grams of amoxicillin on the efficacy and safety of vonoprazan dual therapy. We also assessed the short-term effects of therapy on the gut microbiota and antibiotic resistome.

Methods This was an open-label, randomised trial conducted in 12 centres in China. H. pylori-infected subjects without prior eradication therapy were randomly assigned to receive either vonoprazan (20 mg b.i.d.) with low (1 g b.i.d. or LVA) or high-dose amoxicillin (1 g t.i.d. or HVA) for 14 days. Gastric biopsies were collected during pretreatment to detect antibiotic resistance. Stool samples were collected for shotgun metagenomic sequencing. The primary outcome of this study was the eradication rate of H. pylori using both intention-to-treat and per-protocol analyses. The secondary outcomes included adverse events, adherence, antibiotic resistance rate and alterations of gut microbiota and antibiotic resistome.

Results 504 patients were randomly assigned to LVA or HVA therapy (IDDF2024-ABS-0375 Figure 1). No infections were resistant to amoxicillin. The eradication rates were LVA = 85.3% and HVA = 86.5% (p=0.70) by intention to treat analysis and 88.8% and 92.4% (p=0.18) by per protocol analysis. The efficacy of LVA was non-inferior to HVA in intention to treat analysis (p=0.002) and per protocol analysis (p=0.009) (IDDF2024-ABS-0375 Figure 2). 31 patients (12%) in the LVA group and 43 patients (17%) in the HVA group reported adverse events (p=0.13). Adherence to therapy was 97% in the LVA group and 96% in the HVA group. The diversity of gut microbiota decreased after treatment but was restored to baseline at weeks 8-10 for both groups (IDDF2024-ABS-0375 Figure 3). The alpha diversity of total resistome was increased after treatment but was restored to pretreatment level at weeks 8-10 for both groups (IDDF2024-ABS-0375 Figure 4).

Conclusions LVA therapy was effective and non-inferior to HVA dual therapy as the first-line treatment of H. pylori infection in China. Vonoprazan-amoxicillin dual therapy for 14 days had minimal effects on the gut microbiota and antibiotic resistome.

Abstract IDDF2024-ABS-0375 Figure 1
Abstract IDDF2024-ABS-0375 Figure 1
Abstract IDDF2024-ABS-0375 Figure 2
Abstract IDDF2024-ABS-0375 Figure 2
Abstract IDDF2024-ABS-0375 Figure 3
Abstract IDDF2024-ABS-0375 Figure 3
Abstract IDDF2024-ABS-0375 Figure 4
Abstract IDDF2024-ABS-0375 Figure 4

https://doi.org/10.1136/gutjnl-2024-IDDF.8

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