UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049839 |
|---|---|
| Receipt number | R000056772 |
| Scientific Title | Very Long-Term Treatment with a Lactobacillus Probiotic Preparation, Lactobacillus Casei Strain Shirota |
| Date of disclosure of the study information | 2022/12/21 |
| Last modified on | 2022/12/20 13:49:06 |
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Basic information
Public title
Very Long-Term Treatment with a Lactobacillus Probiotic Preparation, Lactobacillus Casei Strain Shirota
Acronym
ABCD Study
Scientific Title
Very Long-Term Treatment with a Lactobacillus Probiotic Preparation, Lactobacillus Casei Strain Shirota
Scientific Title:Acronym
ABCD Study
Region
| Japan |
Condition
Condition
Colorectal tumors resected
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and mechanism of lactobacillus preparations against various diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
life and death
Key secondary outcomes
Carcinogenesis
Colorectal Disease
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who previously participated in randomized clinical trials of lactobacilli and dietary fiber
Key exclusion criteria
malignant tumors
a history of intestinal or gastric resection, except appendectomy
familial adenomatous polyposis
severe illness
Target sample size
406
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
cancer@gol.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN
Tel
075-251-5337
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 21 | 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
237
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Once a year, we will monitor the status of life, death, and disease by letter.
Management information
Registered date
| 2022 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056772
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
