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

NCT ID: NCT06593834

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2026-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Graft-versus-host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental group

bacillus coagulans combined with the best treatment options for preventing aGVHD

Group Type EXPERIMENTAL

bacillus coagulans combined with the best treatment options for preventing aGVHD

Intervention Type DRUG

BAT means the best treatment options for preventing aGVHD

Control group

The best treatment options for preventing aGVHD

Group Type ACTIVE_COMPARATOR

BAT

Intervention Type DRUG

BAT

Interventions

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bacillus coagulans combined with the best treatment options for preventing aGVHD

BAT means the best treatment options for preventing aGVHD

Intervention Type DRUG

BAT

BAT

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yamin Fan

OTHER

Sponsor Role lead

Responsible Party

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Yamin Fan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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PRS2400084534

Identifier Type: -

Identifier Source: org_study_id

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