UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055714 |
|---|---|
| Receipt number | R000063662 |
| Scientific Title | A study to confirm the effect of lactic acid bacteria intake on intestinal environment - study2: Randomized, placebo-controlled, parallel-group comparison study - |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/01/23 14:10:09 |
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Basic information
Public title
A study to confirm the effect of lactic acid bacteria intake on intestinal environment - study2: Randomized, placebo-controlled, parallel-group comparison study -
Acronym
A study to confirm the effect of lactic acid bacteria intake on intestinal environment
Scientific Title
A study to confirm the effect of lactic acid bacteria intake on intestinal environment - study2: Randomized, placebo-controlled, parallel-group comparison study -
Scientific Title:Acronym
A study to confirm the effect of lactic acid bacteria intake on intestinal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of lactic acid bacteria intake on the intestinal environment in 8-week intervention study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal metabolites
Key secondary outcomes
Gut microbiome
Fecal s-IgA
Fecal amount, days of defecation, frequency of defecation, BSS, fecal color, fecal odor, feeling after defecation
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
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
8-week intake of low dose lactic acid bacteria
Interventions/Control_2
8-week intake of high dose lactic acid bacteria
Interventions/Control_3
8-week intake of placebo (not containing lactic acid bacteria)
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 Japanese males and females ages 20 and over
2) Subjects who have received explanation of the study, have understood its content, and have agreed to participate in the study in writing.
Key exclusion criteria
Subjects
1) who regularly use intestinal regulator or laxative drugs.
2) who have taken antibiotics within 3 weeks before collect the feces.
3) who suffer from a disease requiring urgent treatment.
4) with gastrointestinal diseases affecting digestion and absorption, or with a history of surgery.
5) who participate in a study involving the ingestion of other foods or the use of drugs.
6) who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Soichi |
| Middle name | |
| Last name | Tanabe |
Organization
Ezaki Glico Co., Ltd.
Division name
Applied Research Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL
090-7406-1432
soichi.tanabe@glico.com
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ezaki Glico Co., Ltd.
Division name
Applied Research Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL
050-1752-9714
Homepage URL
taiki.yamaguchi@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
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University
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 555-8502, Japan
Tel
06-6477-8352
kazunori.nishi@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 | 01 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063662
