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GMPA Versus PPI for Gastric Protection and aGVHD Risk

RecruitingNAAges 12 Years - 70 YearsAllFirst Affiliated Hospital of Zhejiang University
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to observe whether different gastric protection strategies affect the incidence of acute graft-versus-host disease (aGVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Proton pump inhibitors (PPIs) are routinely used for gastric protection during transplantation, but their prolonged use may suppress gastric acid, alter gut microbiota, and potentially increase the risk of aGVHD. Teprenone, a gastric mucosal protective agent (GMPA), enhances mucosal defense mechanisms including promoting mucus secretion, increasing gastric mucosal blood flow, and facilitating epithelial cell repair, without affecting gastric acid secretion, and may therefore preserve microbial diversity and modify aGVHD risk. This study compares two strategies: continuous PPI use versus switching from PPIs to teprenone after transplantation. The

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 12-70 years; 2. First allogeneic haploidentical HSCT for hematological malignancy; 3. Treated with a standardized myeloablative conditioning and GVHD prophylaxis regimen; 4. ECOG performance status โ‰ค2 prior to transplant; 5. Written informed consent obtained. Exclusion Criteria: 1. Pre-existing conditions requiring continuous PPI therapy prior to transplant, including severe reflux esophagitis, Zollinger-Ellison syndrome, active peptic ulcer with bleeding, or long-term use of dual antiplatelet agents or oral anticoagulants; 2. Known active, untreated Helicobacter pylori infection prior to transplant; 3. Active infectious enteritis or Clostridioides difficile infection prior to transplant; 4. Use of systemic broad-spectrum antibiotics within 7 days prior to transplant; 5. Use of probiotics within 14 days prior to transplant; 6. Planned total enteral nutrition or oral glutamine supplementation during the study period; 7. Planned parenteral nutrition for โ‰ฅ7 consecutive days; 8. Inability to provide saliva or stool samples for collection; 9. Pregnant or lactating women; 10. History of significant neurological or psychiatric disorders (e.g., epilepsy, dementia) that may interfere with study participation; 11. Life expectancy \<3 months or severe end-organ dysfunction; 12. Any other condition that, in the investigator's judgment, may compromise patient safety, compliance, or the validity of study results.
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What it tests

  • Teprenone
  • Esomeprazole
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Where

1 site
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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