UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025389 |
|---|---|
| Receipt number | 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 | 2026/01/06 13:42:53 |
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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 | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-6-6202-5444
cancer@gol.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-6-6202-5444
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
Kyoto Prefectural University of Medicine
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, 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
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
https://pubmed.ncbi.nlm.nih.gov/41418790/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/41418790/
Number of participants that the trial has enrolled
30
Results
The faecal and mucosal microbiota of the BLP group revealed a high detection rate and abundance of Coprococcus genus and a rich population of butyrate-producing bacteria. RNA-seq of the colon mucosa of BLP-consuming patients revealed high expression of genes related to the oxidative phosphorylation (OXPHOS) pathway, including those of the mitochondrial electron transfer system. Additionally, T cell- and G-protein-coupled receptor-related genes were overexpressed in BLP-consuming patients.
Results date posted
| 2026 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 12 | Month | 17 | Day |
Baseline Characteristics
Participants who had previously enrolled in clinical study designed to evaluate the effects of wheat bran and BLP in preventing colorectal cancer (wheat bran biscuit (WBB)/BLP study) (Ishikawa et al., 2005) were included in this study. Approximately 200 individuals voluntarily continued taking BLP after the (WBB)/BLP study concluded.
They were asked to continue taking the BLP regardless of whether they had been in the BLP group. Participants who desired to continue received BLP. BLP was recommended to be consumed at a dosage of one packet, which contained one gram of LcS preparation, per three times daily following meals. In terms of intake monitoring, participants visited the principal physician's clinic every three months for health evaluations and to verify their adherence to the intake regimen. Most participants adhered to a regimen of three packets per day. In order to avoid rendering the trial infeasible due to overly restrictive exclusion criteria, the exclusion criteria were established to include individuals who had taken antibiotics within one month prior to specimen collection.
Participant flow
Prior to enrolment, participants provided both oral and written informed consent. After obtaining informed consent prior to the trial, nutritional assessments were conducted on the participants using a questionnaire regarding nutritional status over the past one year using Food Frequency Questionnaire (FFQ short version: commissioned from Kenpakusha Co., Ltd.) (Yokoyama et al., 2016). For uniform age and sex distribution, 15 participants who had been taking BLP for more than 20 years were recruited as the intake group, and 15 participants in the non-intake group were recruited as the control group. The principal physician confirmed through medical interviews that, although some participants had chronic conditions, these did not impede their involvement in this trial.
Adverse events
There were no adverse events.
Outcome measures
Analysis of microbiota in feces and colonic mucosa
RNA-seq analysis using colonic mucosa, etc.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029231
