Gastric protection after transplant: switch from PPI to teprenone to see effects on GVHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two gastric-protection strategies in patients undergoing allogeneic haploidentical HSCT. Participants receive either continued esomeprazole (PPI) or a switch to teprenone after transplantation to preserve the gastric mucosa without suppressing acid. The aim is to see how these approaches influence the gut microbiome and the incidence of acute GVHD, with secondary considerations including infection and mortality. Eligible patients are aged 12–70, have hematologic malignancies, and meet disease- and treatment-related criteria. The study is led by the First Affiliated Hospital of Zhejiang University, with no listed collaborators.

Why it matters

Who can join: the full rules

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 ≤2 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 ≥7 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.

Where it's running

• The First Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, China Recruiting

Study contacts

• Study coordinator: Fei Gao
• Email: gf0906@zju.edu.cn
• Phone: +86 19857035073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.