UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057175 |
|---|---|
| Receipt number | R000065359 |
| Scientific Title | Characterization of small intestinal microbiota after Bifidobacterium supplementation -A Randomized, Double-Blind, Placebo Controlled trial- |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2026/03/02 16:02:08 |
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Basic information
Public title
Characterization of small intestinal microbiota after Bifidobacterium supplementation -A Randomized, Double-Blind, Placebo Controlled trial-
Acronym
Characterization of small intestinal microbiota after Bifidobacterium supplementation -A Randomized, Double-Blind, Placebo Controlled trial-
Scientific Title
Characterization of small intestinal microbiota after Bifidobacterium supplementation -A Randomized, Double-Blind, Placebo Controlled trial-
Scientific Title:Acronym
Characterization of small intestinal microbiota after Bifidobacterium supplementation -A Randomized, Double-Blind, Placebo Controlled trial-
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Administering Bifidobacterium to healthy adults undergoing colonoscopy, and after a certain period, collecting and analyzing the surface mucus and ileal fluid from the ileum to investigate the changes in the microbiota and the metabolites.
Basic objectives2
Others
Basic objectives -Others
Analysis of gut microbiota, metabolome, proteome, etc.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of Bifidobacterium in the ileal microflora
Key secondary outcomes
Ileal microbiota analysis, pH and metabolome analysis such as short-chain fatty acids and bile acids, proteome analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single intake of the probiotics food
Interventions/Control_2
Single intake of the placebo food
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Cases undergoing colonoscopy for the purpose of further examination of positive fecal occult blood test, screening, follow-up after endoscopic treatment of colorectal tumors, or for endoscopic treatment of colorectal tumors.
2) Performance Status (ECOG scale): Cases with a score of 0 to 2.
3) Age: Cases aged 20 years or older but under 65 years at the time of registration.
4) Cases with preserved major organ functions and the following bone marrow, liver, and kidney functions:
1 Hemoglobin: 8.0 g/dL or higher
2 White blood cell count: 3,500/mm3 or higher but less than 12,000/mm3
3 Platelet count: 100,000/mm3 or higher
4 Total bilirubin: 1.5 mg/dL or less
5 AST (GOT) and ALT (GPT): 100 IU/L or less
6 ALP: 2 times or less the upper limit of the institution's standard value
7 Creatinine (CRE): Less than 1.5 mg/dL
5) Cases capable of oral intake.
6) Cases from whom written informed consent has been obtained.
Key exclusion criteria
1) Individuals who are using proton pump inhibitors (PPI), vonoprazan (P-CAB), or other gastric acid secretion inhibitors, cholesterol absorption inhibitors, antidiabetic drugs, antihypertensive drugs, antibiotics, antithrombotic drugs, or probiotics and cannot discontinue these medications during the study period.
2) Individuals who cannot discontinue the intake of specific health foods, functional foods, nutritional functional foods, or foods and supplements containing Bifidobacterium during the study period.
3) Individuals with a history of drug or food allergies.
4) Individuals who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
5) Individuals who plan to travel abroad or have overseas travel plans during the study period.
6) Individuals who have participated in other studies involving the intake of foods or drugs, or the application of cosmetics or drugs within the past 4 weeks, are currently participating, or intend to participate.
7) Other cases deemed inappropriate by the physician for participation in this study.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Inoue |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
keninoue71@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Inoue |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
Homepage URL
keninoue71@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
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
京都府立医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065359
