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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025389
Receipt No. R000029231
Scientific Title Preliminary study on the protective effects of habitual intake of BLP on the colorectal tumors
Date of disclosure of the study information 2017/03/31
Last modified on 2019/11/06

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Basic information
Public title Preliminary study on the protective effects of habitual intake of BLP on the colorectal tumors
Acronym Preliminary BLP Study
Scientific Title Preliminary study on the protective effects of habitual intake of BLP on the colorectal tumors
Scientific Title:Acronym Preliminary BLP Study
Region
Japan

Condition
Condition Colorectal tumor (adenoma, adenocarcinoma)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the colorectal tumor regression effect of BLP and to investigate the mechanism of action of BLP
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes RNA from blood;Immunome analysis
Key secondary outcomes "RNA from blood; IgA repartore analysis, PMBC; NK cell activity, Feces; IgA concentration, intestinal microbiota analysis
Normal tissue of the colon; Analysis of Mucosa-Associated Commensal Bacteria"

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
60 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Case group;
The subjects who previously had at least two colorectal tumors removed,
and who have been taking BLP for more than 20 years
Control group;
The subjects who previously had at least two colorectal tumors removed,
and who have not been taking BLP and/or LcS containing products
Key exclusion criteria In the case of treating antibiotics within 4 weeks
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ishikawa
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Molecular-Targeting Cancer Prevention
Zip code
Address 3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL +81-6-6202-5444
Email cancer@gol.com

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Ishikawa
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Molecular-Targeting Cancer Prevention
Zip code
Address 3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL +81-6-6202-5444
Homepage URL
Email cancer@gol.com

Sponsor
Institute Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Yakult Honsha Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Ishikawa Gastroentelogcal Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 03 Month 31 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 30
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
2018 Year 07 Month 02 Day
Date of IRB
2018 Year 10 Month 05 Day
Anticipated trial start date
2018 Year 10 Month 29 Day
Last follow-up date
2020 Year 03 Month 31 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., Takeyama, I., Ishiguro, S., Miyaoka, E,. Sobue, T., and Kakizoe, T.

Management information
Registered date
2016 Year 12 Month 23 Day
Last modified on
2019 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029231

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/11/06 191106UMIN登録.xlsx


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