UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058963 |
|---|---|
| Receipt number | R000067430 |
| Scientific Title | A study on the efficacy of concomitant use of lactic acid bacteria in patients with advanced hepatobiliary cancer undergoing pharmacotherapy |
| Date of disclosure of the study information | 2025/09/02 |
| Last modified on | 2025/09/02 13:40:16 |
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Basic information
Public title
A study on the efficacy of concomitant use of lactic acid bacteria in patients with advanced hepatobiliary cancer undergoing pharmacotherapy
Acronym
Study on the efficacy of concomitant use of lactic acid bacteria in patients with advanced hepatobiliary cancer
Scientific Title
A study on the efficacy of concomitant use of lactic acid bacteria in patients with advanced hepatobiliary cancer undergoing pharmacotherapy
Scientific Title:Acronym
Study on the efficacy of concomitant use of lactic acid bacteria in patients with advanced hepatobiliary cancer
Region
| Japan |
Condition
Condition
hepatobiliary cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the concomitant use of lactic acid bacteria enhances the efficacy of pharmacotherapy and reduces its side effects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival after initiation of pharmacotherapy
Key secondary outcomes
Incidence of adverse events associated with pharmacotherapy
Relative dose intensity of pharmacotherapy used at 24 weeks after initiation of ICIs
Progression-free survival following initiation of pharmacotherapy
Changes in gut microbiota, serum bile acids, cytokines, and Functional Assessment of Cancer Therapy-General (Fact-G), dietary survey
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food to the subject, one bottle per day for 24 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older at the time of consent, who are currently receiving outpatient care at the Department of Hepatobiliary Surgery, Kansai Medical University Hospital
2) Patients diagnosed with hepatocellular carcinoma or cholangiocarcinoma who are scheduled to initiate immune checkpoint inhibitor (ICI) therapy
3) Patients who have received sufficient explanation regarding the study, fully understand its content, and voluntarily provide written informed consent to participate
4) Sex: No restrictions
5) Patients with Performance Status of 0 or 1:
PS 0: Fully active, able to carry on all pre-disease performance without restriction
PS 1: Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work (e.g., light housework, office work)
Key exclusion criteria
1) Non Japanese individuals
2) Pregnant or breastfeeding individuals
3) Patients with severe comorbidities
4) Patients with psychiatric disorders or symptoms that make study participation difficult, as determined by the investigator
5) Patients with infectious diseases requiring systemic treatment
6) Individuals with difficulty in natural defecation
7) Patients with cows milk allergy
8) Patients with poorly controlled diabetes mellitus
9) Patients with liver cirrhosis classified as Child-Pugh Grade B or Grade C
10) Patients with a history of prior treatment with ICIs
11) Patients receiving continuous corticosteroid therapy or immunosuppressive agents
12) Patients with a history or current diagnosis of autoimmune disease
13) Patients participating in other interventional clinical trials
14) Any individual deemed inappropriate for participation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kaibori |
Organization
Kansai Medical University
Division name
Department of Hepatobiliary Surgery
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka, Japan
TEL
072-804-0101
kaibori@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Inoue |
Organization
Kansai Medical University
Division name
Department of Hepatobiliary Surgery
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka, Japan
TEL
072-804-2557
Homepage URL
inoue-ky@osaka-seikei.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Meiji Co., Ltd.
IRB Contact (For public release)
Organization
Institutional Review Board of Kansai Medical University Hospital
Address
2-5-1 Shinmachi, Hirakata-shi, Osaka, Japan
Tel
072-804-2440
rinriirb@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067430
