UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023899
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email takuma_h@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City Univesity
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.