UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058497 |
|---|---|
| Receipt number | R000066840 |
| Scientific Title | A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium |
| Date of disclosure of the study information | 2025/07/17 |
| Last modified on | 2025/07/17 10:25:28 |
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Basic information
Public title
A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium
Acronym
A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium
Scientific Title
A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium
Scientific Title:Acronym
A crossover open-label study comparing the gut environment improving effects of two strains of Bifidobacterium
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratory evaluate the effects on the intestinal environment of taking a bifidobacteria-containing supplement (dead bacteria) and a milk drink (live bacteria) for four weeks.
Two different strains of bifidobacteria will be administered to the same study subjects in a crossover manner, and differences in the strains and food form will be evaluated.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal short-chain fatty acid concentrations before and after ingestion of each test food
Key secondary outcomes
Gut microbiota before and after ingestion of each test food
Bow down status (frequency, amount, stool characteristics, defecation condition, feeling of refreshment) for one week before and after ingestion of each test food
Amount of each Bifidobacterium before and after ingestion of each test food
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the test food (supplement A) for 4 weeks, then take another test food (supplement B) for 4 weeks after washout.
Interventions/Control_2
Intake of test food (dairy drink A) for 4 weeks, then take another test food (dairy drink B) for 4 weeks after washout.
Interventions/Control_3
Intake the test food (supplement B) for 4 weeks, then take another test food (supplement A) for 4 weeks after washout.
Interventions/Control_4
Intake of test food (dairy drink B) for 4 weeks, then take another test food (dairy drink A) for 4 weeks after washout.
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. Subjects aged 20 to 65 at the time of obtaining consent
2. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1.Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2.Subjects receiving treatment for a gastrointestinal disease currently or those who have had gastrointestinal surgery
3.Subjects who are suffering from or have a history of a disease that may affect defecation
4.Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for microbiome such as intestinal regulator
5.Subjects who have used antibiotics within the past month
6. Subjects who have continuously consumed foods containing bifidobacterium within the past 3 months
7.Subjects who plan to make significant changes to their lifestyle (e.g., diet, sleep, exercise) during the study period
8. Subjects with smoking habits
9. Subjects with irregular lifestyles due to night shifts
10. Subjects who have allergies to the test food
11.Female subjects who are pregnant or lactating, or intending to become pregnant during the study
12.Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
13. Subjects deemed unsuitable by the investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Fukao |
Organization
NISSIN YORK CO., LTD.
Division name
Development Laboratories
Zip code
348-8549
Address
272, Kamimurakimi Tsutsumine, Hanyu City, Saitama Prefecture
TEL
048-565-4686
masanori.fukao@nissin.com
Public contact
Name of contact person
| 1st name | Senami |
| Middle name | |
| Last name | Nishida |
Organization
NISSIN YORK CO., LTD.
Division name
Development Laboratories
Zip code
348-8549
Address
272, Kamimurakimi Tsutsumine, Hanyu City, Saitama Prefecture
TEL
048-565-4686
Homepage URL
senami.nishida@nissin.com
Sponsor or person
Institute
NISSIN YORK CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN YORK 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
Ueno Asagao Clinic Ethics Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
jimukyoku@tes-h.co.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
| 2025 | Year | 07 | Month | 17 | 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 | 06 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2025 | 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 | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066840
