UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053378 |
|---|---|
| Receipt number | R000060923 |
| Scientific Title | A study to confirm the effect of continuous ingestion of food containing bifidobacteria to improve gut microbiota |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2024/01/17 14:39:28 |
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Basic information
Public title
A study to confirm the effect of continuous ingestion of food containing bifidobacteria to improve gut microbiota
Acronym
A study to confirm the effect of continuous ingestion of food containing bifidobacteria to improve gut microbiota
Scientific Title
A study to confirm the effect of continuous ingestion of food containing bifidobacteria to improve gut microbiota
Scientific Title:Acronym
A study to confirm the effect of continuous ingestion of food containing bifidobacteria to improve gut microbiota
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 effects of consumption of the test food on the gut microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal bifidobacteria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of an enteric capsule containing bifidobacteria for 2 weeks.
Interventions/Control_2
Ingestion of a capsule containing bifidobacteria for 2 weeks.
Interventions/Control_3
Ingestion of an enteric capsule without bifidobacteria for 2 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy adult men and women who defecate at least five times a week.
2. Subjects who have received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Key exclusion criteria
1. Subjects who regularly use intestinal or laxative drugs (including laxatives).
2. Subjects who ingested antibiotics within one month of the start of the study.
3. Heavy alcohol drinkers (consuming more than 60 g/day of alcohol) or alcoholics.
4. Subjects who regularly consume fermented milk or lactic acid bacteria beverages containing lactobacilli or bifidobacteria, and foods for specified health uses or foods with functional claims (including supplements) containing large amounts of oligosaccharides and are unable to stop during the study period.
5. Subjects who consume foods high in viable bacteria or high in dietary fiber daily and are unable to refrain from them during the examination period.
6. Subjects suffering from a disease requiring urgent treatment or those with serious complications.
7. Subjects with gastrointestinal diseases affecting digestion and absorption, or with a history of surgery.
8. Subjects with food allergies.
9. Subjects who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
10. Subjects participating in a study involving the ingestion of other foods or the use of drugs.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Saito |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-0021
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
06-6477-8352
yasuo.saito@glico.com
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Tsukamoto |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-0021
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
06-6477-8352
Homepage URL
masashi.tsukamoto@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
Tel
06-6477-8352
toshihiko.koike@glico.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 30 | 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
| 2023 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060923
