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Switching stomach drugs after transplant may tame a deadly immune attack

NCT ID NCT07791849

Disease control Sponsor: First Affiliated Hospital of Zhejiang University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether changing from acid-blocking drugs to a stomach-lining protector called teprenone after a stem cell transplant can reduce the risk of acute graft-versus-host disease (aGVHD), a serious complication where donor immune cells attack the recipient's body. About 198 people undergoing their first allogeneic stem cell transplant will be randomly assigned to either continue taking esomeprazole or switch to teprenone for 100 days. Researchers will track aGVHD rates, gut and mouth bacteria changes, infections, and survival for up to a year. The idea is that preserving stomach acid may keep gut bacteria healthier and lower the chance of aGVHD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Teprenone, a gastric mucosal protective agent that shields the stomach lining without blocking acid, compared with continued use of esomeprazole, a proton pump inhibitor.
What this could lead to
If switching to teprenone works, it could reduce the risk of acute graft-versus-host disease after stem cell transplants, potentially improving survival and quality of life for transplant recipients.
What could go wrong
This is a single-center trial, and the benefit is uncertain. Teprenone may not lower aGVHD risk, and participants could still experience infections or other transplant complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 198 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease hematopoietic and lymphoid cell neoplasm Infections infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AGVHD Hematopoietic stem cell transplantation (HSCT) Infection Microbiome Mortality

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310003, China

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