GMPA Versus PPI for Gastric Protection and aGVHD Risk

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT07791849
Status
Recruiting
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Conditions

  • Hematopoietic Stem Cell Transplantation (HSCT)
  • Infection
  • Microbiome
  • Mortality
  • aGVHD

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Teprenone — DRUG
    Teprenone acts by enhancing gastric mucosal defense mechanisms, including promoting mucus secretion, increasing gastric mucosal blood flow, and facilitating epithelial cell repair, without affecting gastric acid secretion. The switch from PPI to teprenone is intended to maintain gastric protection while potentially preserving gut microbial diversity and reducing the risk of acute graft-versus-host disease (aGVHD).
  • Esomeprazole — DRUG
    Continuous PPI use suppresses gastric acid secretion throughout the peri-transplantation period, which may alter gut microbiota composition and potentially influence aGVHD risk.

Study Details

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 main questions this study aims to answer are: * Does switching from PPIs to teprenone after transplantation reduce the cumulative incidence of aGVHD within +100 days post-transplantation compared with continuous PPI use? * What adverse events do participants experience with teprenone versus continuous PPI therapy? * Does teprenone therapy provide better preservation of gut microbial diversity and lower rates of gastrointestinal and infectious complications compared with continuous PPI use? In this prospective, randomized, parallel-controlled, single-center trial, approximately 198 patients undergoing allo-HSCT will be enrolled and assigned in a 1:1 ratio using a central randomization system. The experimental group (teprenone group) will receive standard-dose PPIs (esomeprazole, 40 mg/d, intravenous/oral) during conditioning and switch to teprenone (50 mg tid, orally) after transplantation through day +100. The control group (PPI group) will receive continuous standard-dose PPIs from conditioning through day +100. Probiotic use is prohibited from conditioning through day +100 in both groups. All other anti-infective, GVHD prophylaxis, and supportive care regimens are identical between the two groups. The primary endpoint of this study is the cumulative incidence of aGVHD within +100 days post-transplantation. Secondary endpoints include grade II-IV and grade III-IV aGVHD, lower gastrointestinal aGVHD, steroid-refractory aGVHD, gut and salivary microbiome dynamics (α-diversity, β-diversity, and specific taxa at pre-conditioning, day 0, day +14, and day +28), plasma biomarkers related to intestinal barrier integrity, systemic inflammation, and immune regulation , infectious and gastrointestinal complications (febrile neutropenia, diarrhea, C. difficile infection, bacteremia, EBV/CMV reactivation, upper GI bleeding, reflux), and 1-year survival outcomes (non-relapse mortality, overall survival, GVHD-free/relapse-free survival). During the study, participants will: * Receive the assigned gastric protection regimen (teprenone or PPI) according to randomization * Undergo regular assessments for safety and efficacy monitoring, including aGVHD surveillance and infection screening * Provide fecal and saliva samples at pre-conditioning, day 0, day +14, and day +28 post-transplantation for microbiome analysis * Provide peripheral blood samples at pre-conditioning, day 0, day +14, and day +28 post-transplantation for exploratory analysis * Be followed for up to 1 year post-transplantation

Key Dates

First listed
Aug 28, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Sep 15, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: GMPA group
    Participants in this arm will receive standard-dose proton pump inhibitor (PPI) during the conditioning phase. After transplantation, they will switch to teprenone, a gastric mucosal protective agent, at a dose of 50 mg three times daily (tid), administered orally, from the day of stem cell infusion through day +100 post-transplantation.
  • Placebo Comparator: PPI Group
    Participants in this arm will receive continuous standard-dose proton pump inhibitor (PPI) therapy with esomeprazole at 40 mg daily, administered either intravenously or orally, from the start of conditioning through day +100 post-transplantation.

Primary Outcome Measure

Incidence of acute graft-versus-host disease (aGVHD) post-transplantation [ Time Frame: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first ]

Central Contacts

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