UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054286 |
|---|---|
| Receipt number | R000061998 |
| Scientific Title | Efficacy Confirmation Test for Regular Intake -Preliminary validation of efficacy (improvement of bowel movements, anti-obesity, immunomodulation) of lactobacilli intake in healthy subjects |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2024/04/30 11:49:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy Confirmation Test for Regular Intake -Preliminary validation of efficacy (improvement of bowel movements, anti-obesity, immunomodulation) of lactobacilli intake in healthy subjects
Acronym
Preliminary validation of efficacy (improvement of bowel movements, anti-obesity, immunomodulation) when lactic acid bacteria-containing foods are ingested
Scientific Title
Efficacy Confirmation Test for Regular Intake -Preliminary validation of efficacy (improvement of bowel movements, anti-obesity, immunomodulation) of lactobacilli intake in healthy subjects
Scientific Title:Acronym
Preliminary validation of efficacy (improvement of bowel movements, anti-obesity, immunomodulation) when lactic acid bacteria-containing foods are ingested
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory validation of the efficacy of a normal amount of the test food consumed over a period of time
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Allergy Score
Key secondary outcomes
Weight and body fat changes, bowel movement questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one tablet of the test food per day for 4 weeks
Interventions/Control_2
One tablet of control food per day for 4 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Healthy Japanese women who are between 18 and 60 years of age at the time of consent.
(2) Patients who are not receiving any treatment, whether seasonal, chronic, or sudden, by means of drugs, therapy, or treatment.
(3) Participants who fully understand the content of the clinical research and agree in writing of their own free will to participate in this clinical research.
(4) Patients whose body temperature is between 35.5 and 37.0.
(5) Patients who are able to prohibit binge eating and drinking based on three meals a day during the period of this clinical research.
(6) Patients who are able to use appropriate contraception during the period of this clinical research.
(7) Patients who are able to understand and comply with the administrative rules during this clinical research period.
Key exclusion criteria
(1) Persons with diseases of the gastrointestinal tract, liver, kidney, heart, and circulatory system that affect absorption, distribution, metabolism, and excretion of the test food.
(2) Patients with a history of major surgery on the gastrointestinal tract site such as gastrectomy, gastrointestinal suture, or intestinal resection (excluding polypectomy and appendectomy)
(3) Those with a history of cerebrovascular disease
(4) Those with hypersensitivity or specific constitution such as food allergy related to the test food
(5) Patients suspected of alcohol or drug dependence
(6) Patients who have participated in other clinical trials or clinical research within the past 84 days from the date of consent
(7) Donated 400mL blood within the past 84 days, 200mL blood within the past 28 days, or donated blood components (plasma and platelet components) within the past 14 days from the date of consent.
(8) Those who are lactating or pregnant.
(9) Those who are engaged in night shift.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Nishida |
Organization
Toukai Gakuen University
Division name
School of Health and Nutrition
Zip code
468-8514
Address
2-901 Nakahhira, Tenpaku-ku, Nagoya-city, 468-8514, Japan
TEL
052-801-1472
nishid-y@tokaigakuen-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhisa |
| Middle name | |
| Last name | Nishimura |
Organization
ICHIBIKI Co., LTD.
Division name
Research Laboratory
Zip code
441-8019
Address
110-2 Kinuta, Hanada-cho, Toyohashi-city, Aichi, 441-8019, Japan
TEL
0532328776
Homepage URL
tecnicalcenter@ichibiki.co.jp
Sponsor or person
Institute
Tokai Gakuen University
Institute
Department
Personal name
Yoshio Nishida
Funding Source
Organization
ICHIBIKI Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai Gakuen University Research Ethics Committee
Address
2-901 Nakahhira, Tenpaku-ku, Nagoya-city, 468-8514, Japan
Tel
052-801-1201
nishid-y@tokaigakuen-u.ac.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
| 2026 | Year | 05 | 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
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
| 2024 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 25 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061998
