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NCT Number: NCT06593834

A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation

To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation

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Key information

Conditions

Acute Graft-versus-host Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study is conducted on patients after hematopoietic stem cell transplantation and the intervention is Bacillus coagulans, aiming to investigate the preventive effect of Bacillus coagulans on acute graft-versus-host disease after hematopoietic stem cell transplantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are fully aware of the study, voluntarily participate and sign informed consent;
  • Age: ≥18 years old;
  • Patients with hematologic malignancies undergoing allo-HSCT and patients with severe aplastic anemia (SAA) undergoing allo-HSCT were treated with myeloablative conditioning (MAC).

Exclusion criteria

  • Refused to participate in this clinical study;
  • Unable to take the drug orally;
  • Allergic to Bacillus coagulans;
  • People take allo-HSCT with reduced intensity conditioning (RIC) and nonmyeloablative conditioning (NMC);lymphoma or multiple myeloma with auto-HSCT; multiple myeloma patients.

Treatment and study plan

bacillus coagulans combined with the best treatment options for preventing aGVHD

Drug

BAT means the best treatment options for preventing aGVHD

BAT

Drug

BAT

Primary outcomes

  1. Rate of acute graft-versus-host disease

    Time frame: 100th day

    Will acute graft-versus-host disease occur within 100 days after hematopoietic stem cell transplantation and its probability of occurrence

Sponsors and collaborators

Lead sponsor

Yamin Fan

Other

Registry information

Official study title

A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease (aGVHD) After Hematopoietic Stem Cell Transplantation

Acronym: aGVHD；BAT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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