UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051459 |
|---|---|
| Receipt number | R000058700 |
| Scientific Title | Preliminary test : The study to confirm the safety of eating food containing lactic acid bacteria |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/01/31 18:15:58 |
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Basic information
Public title
Preliminary test : The study to confirm the safety of eating food containing lactic acid bacteria
Acronym
Preliminary test : The study to confirm the safety of eating food containing lactic acid bacteria
Scientific Title
Preliminary test : The study to confirm the safety of eating food containing lactic acid bacteria
Scientific Title:Acronym
Preliminary test : The study to confirm the safety of eating food containing lactic acid bacteria
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of eating food containing lactic acid bacteria
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety evaluation of eating food containing lactic acid bacteria for 4 weeks
Key secondary outcomes
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects eat food containing lactic acid bacteria for 4 weeks
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who eat three regular meals
2) Subjects who can abstain from alcohol for 2 days prior to each examination
3) Subjects who don't have recurrent episodes of constipation and diarrhea
4) Subjects who don't have any serious complications
Key exclusion criteria
1) Subjects who are suffering or undergoing treatment or with a history of diabetes mellitus, renal or hepatic disease, cardiac disease or other serious disease, thyroid disease, adrenal disease, psychiatric disease, autoimmune disease, or other metabolic disease (excluding subjects who approved by the principal investigator to participate in the study)
2) Subjects who are lactose intolerant
3) Subjects who can't stop taking foods containing lactobacilli, bifidobacteria, oligosaccharides, or other live bacteria during the study
4) Subjects who regularly eat supplements or health foods (including food for specified health uses) that may affect immunity
5) Subjects who have taken antibiotics within one month of the study
6) Subjects who are regularly taking laxatives, intestinal preparations, etc.
7) Subjects who are pregnant, intend to become pregnant during the research period, or are breastfeeding
8) Subjects who are constantly consuming alcohol over the appropriate level (an average of approximately 20 g of pure alcohol per day)
9) Subjects who are allergic to medicines or food
10) Subjects who have chronic diseases and regularly use medicines
11) Subjects who have a history of gastrointestinal diseases affecting digestion and absorption or a history of gastrointestinal surgery (excluding appendicitis)
12) Subjects who have no abnormal blood test results from a physical examination within the past year
13) Subjects who are suffering from an illness that requires urgent treatment
14) Subjects with a history or current history of drug or alcohol dependence
15) Subjects who are currently participating or intend to participate in a study (trial) involving the ingestion of other foods or the use of medicines, or the application of cosmetics or pharmaceuticals
Target sample size
6
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
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL
+81-6-6477-8793
yasuo.saito@glico.com
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Nishimura |
Organization
EZAKI GLICO Co., Ltd.
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL
+81-6-6477-8793
Homepage URL
kana.nishimura@glico.com
Sponsor or person
Institute
EZAKI GLICO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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, 555-8502, Japan
Tel
+81-6-6477-8793
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
| 2024 | Year | 07 | Month | 01 | 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
6
Results
Six healthy male and female adults consumed food containing lactic acid bacteria for 4 weeks. As a result, no serious adverse events caused by consumption of lactic acid bacteria were observed. In addition, there were no abnormal changes in blood test, urinalysis, physical measurement and blood pressure measurement due to consumption of lactic acid bacteria.
Results date posted
| 2024 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Number of Intention To Treat: 6
Number of Full Analysis Set: 6
Number of Per Protocol Set: 6
Participant flow
Adverse events
Some subjects had adverse events such as rhinitis and diarrhea, but since the symptoms were temporary and recovered during the study period, it was judged to be a contraindicated event and not causally related to the study.
Outcome measures
The following were evaluated before ingestion and after 2 and 4 weeks of intake
Blood test
Urinalysis
Physical measurements
Blood pressure measurement
History taking
In addition, a logbook was taken during the study
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 08 | Month | 25 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058700
