UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059209 |
|---|---|
| Receipt number | R000067720 |
| Scientific Title | Additional validation of a study on short-chain fatty acid production by taking probiotics |
| Date of disclosure of the study information | 2025/09/26 |
| Last modified on | 2025/09/26 17:29:15 |
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Basic information
Public title
Additional validation of a study on short-chain fatty acid production by taking probiotics
Acronym
Additional validation of a study on short-chain fatty acid production by taking probiotics
Scientific Title
Additional validation of a study on short-chain fatty acid production by taking probiotics
Scientific Title:Acronym
Additional validation of a study on short-chain fatty acid production by taking probiotics
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the amount of short-chain fatty acids produced by ingesting B. lactis GCL2505.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
organic acids concentration in feces
Key secondary outcomes
gut microbiota, stool volume, number of defecation days, defecation episodes, BSS, stool color, stool odor, feeling after defecation, Subjective questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
3-week intake of B. lactis GCL2505
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese males and females from 20 to 65 years old.
2) Subjects who are able to collect and send the required amount of fecal samples within the designated period (with stable bowel movements)
3) Subjects who reside in the Tokyo metropolitan area or the Sapporo area during the study period
4) Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing
Key exclusion criteria
Subjects
1) who have a severe liver, kidney, heart, respiratory, endocrine, or metabolic disorders, or immunodeficiency.
2) who are taking medication for diabetes.
3) who suffer from a disease requiring urgent treatment or who have serious complications.
4) who have a history of or current drug or alcohol dependence.
5) who have recurrent gastrointestinal symptoms such as constipation or diarrhea.
6) who regularly consume alcohol (consuming more than 40 g/day of alcohol).
7) who are smokers.
8) who have extremely irregular eating habits.
9) who are unable to discontinue the intake of Foods for Specified Health Uses (FOSHU), foods with functional claims, nutritional supplements, or dietary supplements during the study period.
10) who have allergies to any food components contained in the study food.
11) who have taken antibiotics within one month before the start of intake.
12) who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
13) who are currently participating in, or intend to participate in, other clinical studies involving foods, drugs, cosmetics, or pharmaceuticals.
14) deemed ineligible by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Soichi |
| Middle name | |
| Last name | Tanebe |
Organization
Ezaki Glico Co., Ltd.
Division name
Applied Research Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka 555-8502, Japan
TEL
050-1751-1427
soichi.tanabe@glico.com
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo 105-0023, Japan
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KSO Corporation, Watanabe Hospital, Higashinaebo Hospital, Kanamori Giken Co.,Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Watanabe Hospital
Address
1-5-16 Haneda, Ota-ku, Tokyo 144-0043, Japan
Tel
03-3741-0223
wnb.cto@gmail.com
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
医療法人社団 渡辺病院(東京都)、社会医療法人 豊生会 東苗穂病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 27 | 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 | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067720
