Acute Graft-versus-host Disease
Conditions
Brief summary
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
DRUGbacillus coagulans combined with the best treatment options for preventing aGVHD
BAT means the best treatment options for preventing aGVHD
DRUGBAT
BAT
Sponsors
Yamin Fan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of acute graft-versus-host disease | 100th day | Will acute graft-versus-host disease occur within 100 days after hematopoietic stem cell transplantation and its probability of occurrence |
Outcome results
None listed