NCT06593834

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

September 3, 2024

Last Update Submit

September 22, 2024

Conditions

Acute Graft-versus-host Disease

Outcome Measures

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

    100th day

Study Arms (2)

Experimental group

EXPERIMENTAL

bacillus coagulans combined with the best treatment options for preventing aGVHD

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

Control group

ACTIVE COMPARATOR

The best treatment options for preventing aGVHD

Drug: BAT

Interventions

bacillus coagulans combined with the best treatment options for preventing aGVHDDRUG

BAT means the best treatment options for preventing aGVHD

Experimental group
BATDRUG

BAT

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

September 27, 2024

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

September 25, 2024

Record last verified: 2024-09