UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023899 |
|---|---|
| Receipt number | R000027524 |
| Scientific Title | The efficacy of bifidobacterium preparation LKM512 for rectal aberrant crypt foci: A double-blind randomized controlled trial |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2019/03/13 22:37:46 |
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Basic information
Public title
The efficacy of bifidobacterium preparation LKM512 for rectal aberrant crypt foci: A double-blind randomized controlled trial
Acronym
LKM512 for rectal ACF
Scientific Title
The efficacy of bifidobacterium preparation LKM512 for rectal aberrant crypt foci: A double-blind randomized controlled trial
Scientific Title:Acronym
LKM512 for rectal ACF
Region
| Japan |
Condition
Condition
Patients with both resectable colorectal adenoma/carcinoma in situ by colonoscopy and rectal ACF
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficaty of Bifidobacterium preparation LKM512 for rectal aberranty crypt foci
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
The amount of change of rectal ACF
Key secondary outcomes
The change of microbiota
Safety
The cell-proliferative and apoptotic activities in the colorectal epithelium and adenoma/cancer
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food |
Interventions/Control_1
receive oral LKM512 powder 1g per day for 2 month
Interventions/Control_2
receive oral placebo powder per day for 2 month
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with both colorectal ACF and resectable adenoma/cancer.
2.Willingness to provide written informed consent
Key exclusion criteria
1.History of regular use of Lactobacillous, Bifidobacterium preparation supplements.
2.History of regular use (defined as at least once per week) of NSAIDs and/or aspirin.
3.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
4.History of familial adenomatous polyposis
5.History of hereditary non-polyposis colorectal cancer
6.History of inflammatory bowel disease
7.Pregnancy or possibility of pregnancy
8.Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City Univesity
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
takuma_h@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City Univesity
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City Univesity
Institute
Department
Personal name
Funding Source
Organization
(WAKATE-B) from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital IRB
Address
3-9 Fukuura Kanazawa-ku Yokohama City
Tel
81-45-787-2640
takuma_h@yokohama-cu.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
| 2016 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027524
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| Registered date | File name |
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