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

Not Applicable

Not yet recruiting

• Conditions: Acute Graft-versus-host Disease
• Interventions: Drug: bacillus coagulans combined with the best treatment options for preventing aGVHD; Drug: BAT

• Registration Number: NCT06593834
• Lead Sponsor: Yamin Fan

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-08
• Last Update Submitted: 2024-09-08
• Study Start: 2024-09-09
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 508

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). lymphoma or multiple myeloma with auto-HSCT; multiple myeloma patients;

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	bacillus coagulans combined with the best treatment options for preventing aGVHD	bacillus coagulans combined with the best treatment options for preventing aGVHD
Control group	BAT	The best treatment options for preventing aGVHD

Primary Outcome Measures

Name	Time	Method
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