UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057515 |
|---|---|
| Receipt number | R000065718 |
| Scientific Title | Analysis of host cells affected by long-term ingestion of Lacticaseibacillus preparations using spatial transcriptome analysis |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/10/09 15:33:28 |
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Basic information
Public title
Analysis of host cells affected by long-term ingestion of Lacticaseibacillus preparations
Acronym
Analysis of host cells affected by long-term ingestion of Lacticaseibacillus preparations
Scientific Title
Analysis of host cells affected by long-term ingestion of Lacticaseibacillus preparations using spatial transcriptome analysis
Scientific Title:Acronym
Analysis of host cells affected by long-term ingestion of Lacticaseibacillus preparations using spatial transcriptome analysis
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Analysis of host-derived cells affected by taking Lacticaseibacillus preparations in intestinal tissues
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of host-derived cells affected by taking Lacticaseibacillus preparations in intestinal tissues
Key secondary outcomes
Analysis of host immune cells in periphery, intestinal microbiota affected by long-term ingestion of Lacticaseibacillus preparations.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 79 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Case group;
The subjects who previously had at least two polyps removed,
and who have been taking Lacticaseibacillus preparations for more than 20 years
Control group;
The subjects who previously had at least two polyps removed,
and who have not been taking Lacticaseibacillus preparations and/or Yakult products
Key exclusion criteria
In the case of treating antibiotics within 4 weeks
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Ishikawa Gastroenterology Clinic
Division name
Gastroenterology
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-6-6202-6566
cancer@gol.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Ishikawa Gastroenterology Clinic
Division name
Gastroenterology
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-6-6202-6566
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Ishikawa Gastroenterology Clinic
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
Tel
+81-6-6202-5444
rinri@koto.kpu-m.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
石川消化器内科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 30 | 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 | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Randomized trial of dietary fiber and Lactobacillus casei administration for prevention of colorectal tumors.
Int. J. Cancer 116(5)p762-767, 2005 Ishikawa, H., Akedo, I., Otani, T., Suzuki, T., Nakamura, T., Take
yama, I., Ishiguro, S., Miyaoka, E,. Sobue, T., and Kakizoe, T.
Very Long-Term Treatment with a Lactobacillus Probiotic Preparation, Lactobacillus casei Strain Shirota, Suppresses Weight Loss in the Elderly
Nutrients. 2020 May 29;12(6):1599. doi: 10.3390/nu12061599.
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065718
