AzTrials
AzTrials

Hematopoietic Stem Cell Transplantation (HSCT)NCT07791849

GMPA Versus PPI for Gastric Protection and aGVHD Risk

A study testing Teprenone and Esomeprazole in people with Hematopoietic Stem Cell Transplantation (HSCT) and aGVHD, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 12 to 70 years
What is being tested?
Teprenone and Esomeprazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
198 participants
Where
1 siteChina
Study dates
15 Sep 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age 12-70 years;
  • First allogeneic haploidentical HSCT for hematological malignancy;
  • Treated with a standardized myeloablative conditioning and GVHD prophylaxis regimen;
  • ECOG performance status ≤2 prior to transplant;
  • Written informed consent obtained.

Who cannot join

  • 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;
  • Known active, untreated Helicobacter pylori infection prior to transplant;
  • Active infectious enteritis or Clostridioides difficile infection prior to transplant;
  • Use of systemic broad-spectrum antibiotics within 7 days prior to transplant;
  • Use of probiotics within 14 days prior to transplant;
  • Planned total enteral nutrition or oral glutamine supplementation during the study period;
Show all 12Show fewer
  • Planned parenteral nutrition for ≥7 consecutive days;
  • Inability to provide saliva or stool samples for collection;
  • Pregnant or lactating women;
  • History of significant neurological or psychiatric disorders (e.g., epilepsy, dementia) that may interfere with study participation;
  • Life expectancy <3 months or severe end-organ dysfunction;
  • Any other condition that, in the investigator's judgment, may compromise patient safety, compliance, or the validity of study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fei Gao contact

+86 19857035073

gf0906@zju.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310003

    gf0906@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Comparative Effect of Proton Pump Inhibitors and Gastric Mucosal Protective Agents on Acute Graft-versus-Host Disease Post-Transplantation: A Prospective Randomized Controlled Trial

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:

Read more
  • 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
Being tested
Teprenone, Esomeprazole
Keywords
hematopoietic stem cell transplantation, PPI, GMPA, acute graft versus host disease, microbiome
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeprenoneDrug

    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).

  • EsomeprazoleDrug

    Continuous PPI use suppresses gastric acid secretion throughout the peri-transplantation period, which may alter gut microbiota composition and potentially influence aGVHD risk.

Study groups in NCT07791849
Study groupRoleWhat they receive
GMPA groupExperimentalParticipants 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.
Receives: Drug: Teprenone
PPI GroupPlacebo comparatorParticipants 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.
Receives: Drug: Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of acute graft-versus-host disease (aGVHD) post-transplantation

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

Secondary outcomes (15)

  1. Incidence of grade II-IV acute graft-versus-host disease (aGVHD)

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  2. Incidence of grade III-IV acute graft-versus-host disease (aGVHD)

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  3. Incidence of lower gastrointestinal aGVHD

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  4. Oral microbiome diversity and composition

    Measured: At pre-conditioning, Day +0, Day +14, and Day +28 post-transplantation

  5. Fecal microbiome diversity and composition

    Measured: At pre-conditioning, Day +0, Day +14, and Day +28 post-transplantation

  6. Incidence of febrile neutropenia

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  7. Incidence of diarrhea

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  8. Incidence of Clostridioides difficile infection

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up

  9. Incidence of enterococcal colonization/infection

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  10. Incidence of bacteremia

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  11. Incidence of upper gastrointestinal bleeding

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  12. Incidence of clinically significant reflux symptoms

    Measured: From Day 0 to Day +100 post-transplantation, or until death or loss to follow-up, whichever came first

  13. 1-year non-relapse mortality (NRM)

    Measured: From Day 0 to 1 year post-transplantation

  14. 1-year overall survival (OS)

    Measured: From Day 0 to 1 year post-transplantation

  15. 1-year GVHD-free, relapse-free survival (GRFS)

    Measured: From Day 0 to 1 year post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion15 Sep 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791849
Sponsor's protocol ID
GP-aGVHD-001
Status last verified
Aug 2026
First submitted
22 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhu J, Sun C, Li M, Hu G, Zhao XM, Chen WH. Compared to histamine-2 receptor antagonist, proton pump inhibitor induces stronger oral-to-gut microbial transmission and gut microbiome alterations: a randomised controlled trial. Gut. 2024 Jun 6;73(7):1087-1097. doi: 10.1136/gutjnl-2023-330168.

    PubMed 38050061

  • Xiao X, Zhang X, Wang J, Liu Y, Yan H, Xing X, Yang J. Proton pump inhibitors alter gut microbiota by promoting oral microbiota translocation: a prospective interventional study. Gut. 2024 Jun 6;73(7):1098-1109. doi: 10.1136/gutjnl-2023-330883.

    PubMed 38267200

  • Lee I, Jo JW, Woo HJ, Suk KT, Lee SS, Kim BS. Proton pump inhibitors increase the risk of carbapenem-resistant Enterobacteriaceae colonization by facilitating the transfer of antibiotic resistance genes among bacteria in the gut microbiome. Gut Microbes. 2024 Jan-Dec;16(1):2341635. doi: 10.1080/19490976.2024.2341635. Epub 2024 Apr 18.

    PubMed 38634770

  • Weersma RK, Zhernakova A, Fu J. Interaction between drugs and the gut microbiome. Gut. 2020 Aug;69(8):1510-1519. doi: 10.1136/gutjnl-2019-320204. Epub 2020 May 14.

    PubMed 32409589

  • Imhann F, Vich Vila A, Bonder MJ, Lopez Manosalva AG, Koonen DPY, Fu J, Wijmenga C, Zhernakova A, Weersma RK. The influence of proton pump inhibitors and other commonly used medication on the gut microbiota. Gut Microbes. 2017 Jul 4;8(4):351-358. doi: 10.1080/19490976.2017.1284732. Epub 2017 Jan 24.

    PubMed 28118083

  • Zhang X, Li Q, Xia S, He Y, Liu Y, Yang J, Xiao X. Proton Pump Inhibitors and Oral-Gut Microbiota: From Mechanism to Clinical Significance. Biomedicines. 2024 Oct 7;12(10):2271. doi: 10.3390/biomedicines12102271.

    PubMed 39457584

  • Nguyen CL, Funes J, Ghale R, Duong N, Victor K, Gipson B, Zhang ZJ, Dai A, Li R, Armijo G, Huang A, Martinez M, Chen Y, Ghazarian D, Docampo M, Pathak K, Pirrotte P, Markey KA, Peled JU, Paredes J, Burgos da Silva M, van den Brink MRM. Enterococcus faecalis induces MHC-II expression by the intestinal epithelium during murine graft-versus-host disease. Blood. 2026 Mar 26;147(13):1485-1497. doi: 10.1182/blood.2024028248.

    PubMed 41460962

  • Fujimoto K, Hayashi T, Yamamoto M, Sato N, Shimohigoshi M, Miyaoka D, Yokota C, Watanabe M, Hisaki Y, Kamei Y, Yokoyama Y, Yabuno T, Hirose A, Nakamae M, Nakamae H, Uematsu M, Sato S, Yamaguchi K, Furukawa Y, Akeda Y, Hino M, Imoto S, Uematsu S. An enterococcal phage-derived enzyme suppresses graft-versus-host disease. Nature. 2024 Aug;632(8023):174-181. doi: 10.1038/s41586-024-07667-8. Epub 2024 Jul 10.

    PubMed 38987594

  • Stein-Thoeringer CK, Nichols KB, Lazrak A, Docampo MD, Slingerland AE, Slingerland JB, Clurman AG, Armijo G, Gomes ALC, Shono Y, Staffas A, Burgos da Silva M, Devlin SM, Markey KA, Bajic D, Pinedo R, Tsakmaklis A, Littmann ER, Pastore A, Taur Y, Monette S, Arcila ME, Pickard AJ, Maloy M, Wright RJ, Amoretti LA, Fontana E, Pham D, Jamal MA, Weber D, Sung AD, Hashimoto D, Scheid C, Xavier JB, Messina JA, Romero K, Lew M, Bush A, Bohannon L, Hayasaka K, Hasegawa Y, Vehreschild MJGT, Cross JR, Ponce DM, Perales MA, Giralt SA, Jenq RR, Teshima T, Holler E, Chao NJ, Pamer EG, Peled JU, van den Brink MRM. Lactose drives Enterococcus expansion to promote graft-versus-host disease. Science. 2019 Nov 29;366(6469):1143-1149. doi: 10.1126/science.aax3760.

    PubMed 31780560

  • Hayase E, Hayase T, Jamal MA, Miyama T, Chang CC, Ortega MR, Ahmed SS, Karmouch JL, Sanchez CA, Brown AN, El-Himri RK, Flores II, McDaniel LK, Pham D, Halsey T, Frenk AC, Chapa VA, Heckel BE, Jin Y, Tsai WB, Prasad R, Tan L, Veillon L, Ajami NJ, Wargo JA, Galloway-Pena J, Shelburne S, Chemaly RF, Davey L, Glowacki RWP, Liu C, Rondon G, Alousi AM, Molldrem JJ, Champlin RE, Shpall EJ, Valdivia RH, Martens EC, Lorenzi PL, Jenq RR. Mucus-degrading Bacteroides link carbapenems to aggravated graft-versus-host disease. Cell. 2022 Sep 29;185(20):3705-3719.e14. doi: 10.1016/j.cell.2022.09.007.

    PubMed 36179667

  • Gao F, Wu H, Wang L, Zhao Y, Huang H. Altered intestinal microbiome and epithelial damage aggravate intestinal graft-versus-host disease. Gut Microbes. 2023 Jan-Dec;15(1):2221821. doi: 10.1080/19490976.2023.2221821.

    PubMed 37305973

  • van Lier YF, Vos J, Blom B, Hazenberg MD. Allogeneic hematopoietic cell transplantation, the microbiome, and graft-versus-host disease. Gut Microbes. 2023 Jan-Dec;15(1):2178805. doi: 10.1080/19490976.2023.2178805.

    PubMed 36794370

  • Penack O, Marchetti M, Aljurf M, Arat M, Bonifazi F, Duarte RF, Giebel S, Greinix H, Hazenberg MD, Kroger N, Mielke S, Mohty M, Nagler A, Passweg J, Patriarca F, Ruutu T, Schoemans H, Solano C, Vrhovac R, Wolff D, Zeiser R, Sureda A, Peric Z. Prophylaxis and management of graft-versus-host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation. Lancet Haematol. 2024 Feb;11(2):e147-e159. doi: 10.1016/S2352-3026(23)00342-3. Epub 2024 Jan 3.

    PubMed 38184001

Questions about this trial

What is this clinical trial studying?

A study testing Teprenone and Esomeprazole in people with Hematopoietic Stem Cell Transplantation (HSCT) and aGVHD, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fei Gao (+86 19857035073, gf0906@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07791849, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in