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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYamin Fan

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    BAT means the best treatment options for preventing aGVHD

  • BAT

    Drug

    BAT

Treatment groups

286 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of acute graft-versus-host disease

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

Time frame
100th day

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yamin Fan

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: