Probiotic-supplemented gut decontamination Methods in Hematopoietic Stem Cell Transplantation

JRCT ID: jRCTs051240081

Registered date:02/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute leukemia, myelodysplastic syndrome, malignant lymphoma
• Date of first enrollment: 02/07/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

1. CBM588 administration group
CBM588 fine granule 1g is orally administered 3 times daily from 7 days prior to transplantation until 100 days after transplantation.
2. placebo group
Placebo group: 1 g of CBM588 fine granules administered orally 3 times daily from 7 days prior to transplantation until 100 days after transplantation.

Outcome(s)

• Primary Outcome: Change from baseline (7 days before transplantation) in alpha diversity (Shannon index) at 14 days after transplantation

Secondary Outcome

(1) Change from baseline in alpha diversity at each evaluation time point after transplantation
(2) Change from baseline in beta diversity at each time point after transplantation
(3) Change from baseline in Enterococcus and Bacteroides at each post-transplant
evaluation time point
(4) Change from baseline in butyrate-producing bacteria (and Clostridium butyricum)
at each post-transplant evaluation time point
(5) Frequency of onset of diarrhea (Bristol Scale 6 or 7) and duration of diarrhea in those who developed diarrhea after transplantation
(6) Frequency of onset of fever > 38 degrees Celsius after transplantation and
duration of fever
(7) Frequency of febrile neutropenia after transplantation
(8) Types of antimicrobial agents used in the treatment of post-transplant febrile neutropenia and the number of days they were used
(9) Frequency of post-transplant complications including acute GVHD
(10) Recurrence-free survival (including evaluation of non-relapse mortality)
(11) Overall survival
(12) Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

(1) Patients diagnosed with a malignant hematologic disease (acute leukemia, myelodysplastic syndrome, malignant lymphoma) that is an indication for an allogeneic hematopoietic stem cell transplant. Any source of transplant is acceptable.
(2) Age 16 years or older but less than 70 years old.
(3) Persons who have given written consent to participate in this study.

Exclude criteria

(1) Those with Very High DRI
(2) Those with HCT-CI of 3 or more points
(3) Patients who are currently participating in other interventional studies
(4) Other subjects deemed inappropriate by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Fukushima Kentaro
• Secondary Sponsor: Miyarisan Pharmaceutical, Co. Ltd.
• Source(s) of Monetary Support: Japan Society for the Promotion of Science