{
  "abstract": "Background To evaluate the efficacy and safety of optimized highdose tegoprazan (50 mg three times daily) combined with varying amoxicillin doses as firstline treatment for Helicobacter pylori (H. pylori) infection in China.Methods This was a nationwide, multicenter, open-label, randomized controlled, non-inferiority trial conducted across eight hospitals in China. Treatment-naive participants were randomized 1:1:1 to 14-day regimens: LAT (amoxicillin 1 g twice daily + tegoprazan), HAT (amoxicillin 1 g three times daily + tegoprazan), or EBAC (esomeprazole, bismuth, amoxicillin, clarithromycin). Randomization was performed via a centralized web-based system using a permuted block with a block size of six, stratified by study center. Participants and investigators were not masked to group assignment. Stool samples were collected at baseline, week 2 and week 8-10 for shotgun metagenomic sequencing. The primary outcome was eradication rate by 13C-urea breath test, with a non-inferiority margin of -10%. Secondary outcomes included adverse events, adherence, antibiotic resistance and alterations in gut microbiota. The non-inferiority margin was set at -10%.Results 474 participants were randomly assigned ( IDDF2026-ABS-0122 Figure 1). Clarithromycin and levofloxacin resistance rates were 35% and 25%. The eradication rate was 72.2% (114/158; 95% CI 64.7 to 78.6) for LAT, 86.7% (137/158; 80.5 to 91.1) for HAT, and 88.6% (140/158; 82.7 to 92.7) for EBAC in the intention-to-treat analysis. HAT was non-inferior to EBAC (risk difference -1.9%, 95% CI -9.3 to 5.5), while LAT was not (IDDF2026-ABS-0122 Figure 2). Treatment-emergent adverse events occurred in 16% in LAT, 14% in HAT, and 27% in EBAC (p<0.05). Adherence was 94% in LAT, 96% in HAT, and 96% in EBAC. The diversity of gut microbiota decreased, whereas the diversity of antibiotic resistance genes increased immediately posttreatment, both of which had returned to baseline levels by weeks 8-10 in the LAT and HAT groups, but not in the EBAC group (IDDF2026-ABS-0122 Figure 3, IDDF2026-ABS-0122 Figure 4).Conclusions The 14-day HAT regimen was non-inferior to EBAC for H. pylori eradication with better safety, offering a promising first-line option amid rising clarithromycin resistance.Abstract IDDF2026-ABS-0122 Figure 1Abstract IDDF2026-ABS-0122 Figure 2Abstract IDDF2026-ABS-0122 Figure 3Abstract IDDF2026-ABS-0122 Figure 4",
  "authors": [
    {
      "affiliations": [
        "Jiangxi Provincial Key Laboratory of Digestive Diseases, Department of Gastroenterology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China"
      ],
      "name": "Yi Hu"
    },
    {
      "affiliations": [
        "Jiangxi Provincial Key Laboratory of Digestive Diseases, Department of Gastroenterology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China"
      ],
      "name": "Xin Xu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China"
      ],
      "name": "Zhen-Yu Zhang"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, The Third People’s Hospital of Jingdezhen, Jingdezhen, Jiangxi province, China"
      ],
      "name": "Li Yang"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Xi’an Central Hospital, College of Medicine, Xi’an Jiaotong University, Xi’an, China"
      ],
      "name": "Kun Zhuang"
    },
    {
      "affiliations": [
        "Jiangxi Provincial Key Laboratory of Digestive Diseases, Department of Gastroenterology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China"
      ],
      "name": "Guan-Yue Wei"
    },
    {
      "affiliations": [
        "Department of Surgery at the Sir YK Pao Centre for Cancer, The Chinese University of Hong Kong, Hong Kong, China"
      ],
      "name": "Yu-Juan Dong"
    },
    {
      "affiliations": [
        "Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China"
      ],
      "name": "Ka-Shing Cheung"
    },
    {
      "affiliations": [
        "Department of Medicine, Michael E. DeBakey VA Medical Center, and Baylor College of Medicine, Houston, United States"
      ],
      "name": "David Graham"
    },
    {
      "affiliations": [
        "Jiangxi Provincial Key Laboratory of Digestive Diseases, Department of Gastroenterology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China"
      ],
      "name": "Nong-Hua Lu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Shenzhen University General Hospital, Shenzhen, China"
      ],
      "name": "Long Xu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hunan Key Laboratory of Non-Resolving Inflammation and Cancer, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China"
      ],
      "name": "Fen Wang"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Peng Li"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China"
      ],
      "name": "Yi-Qi Du"
    },
    {
      "affiliations": [
        "Jiangxi Provincial Key Laboratory of Digestive Diseases, Department of Gastroenterology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China"
      ],
      "name": "Yin Zhu"
    }
  ],
  "title": "IDDF2026-ABS-0122 Tegoprazan and low- or high-dose amoxicillin dual therapy versus bismuth plus clarithromycin-based triple therapy for helicobacter pylori eradication (TREAT): a multicenter, open-label, non-inferiority, randomized controlled trial",
  "uid": "98a4cc3e-d9c5-52ab-aa88-71452188af34"
}