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

Y

Yamin Fan

Status

Not yet enrolling

Conditions

Acute Graft-versus-host Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06593834
PRS2400084534

Details and patient eligibility

About

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

Full 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.

Enrollment

286 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients are fully aware of the study, voluntarily participate and sign informed consent;
  2. Age: ≥18 years old;
  3. 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

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

286 participants in 2 patient groups

Experimental group
Experimental group
Description:
bacillus coagulans combined with the best treatment options for preventing aGVHD
Treatment:
Drug: bacillus coagulans combined with the best treatment options for preventing aGVHD
Control group
Active Comparator group
Description:
The best treatment options for preventing aGVHD
Treatment:
Drug: BAT

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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