NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051240081

Registered date:02/07/2024

Probiotic-supplemented gut decontamination Methods in Hematopoietic Stem Cell Transplantation

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedacute leukemia, myelodysplastic syndrome, malignant lymphoma
Date of first enrollment02/07/2024
Target sample size100
Countries of recruitment
Study typeInterventional
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 OutcomeChange 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
GenderBoth
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

Contact

Public contact
Name Kentaro Fukushima
Address 2-2-C9, Yamada-oka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3871
E-mail kfukushi@bldon.med.osaka-u.ac.jp
Affiliation Osaka University Graduate School of Medicine
Scientific contact
Name Kentaro Fukushima
Address 2-15, Yamada-oka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-5111
E-mail kfukushi@bldon.med.osaka-u.ac.jp
Affiliation Osaka University Hospital