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Not yet recruiting NCT06593834

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

No phase Interventional Acute Graft-versus-host Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bacillus coagulans combined with the best treatment options for preventing aGVHD, BAT.
Who it may be relevant to
Registry conditions: Acute Graft-versus-host Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Drug bacillus coagulans combined with the best treatment options for preventing aGVHD
    BAT means the best treatment options for preventing aGVHD
  • Drug BAT
    BAT

Primary outcome measures

  • Rate of acute graft-versus-host disease [Time frame: 100th day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06593834 · PRS2400084534

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗